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The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Island Dental Lab Inc. DBA Emerald Dental Lab
Emerald Herbst
In Commercial Distribution
- DR6037018 ()
- Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Island Dental Lab Inc. DBA Emerald Dental Lab
Emerald Herbst
In Commercial Distribution
- DR5071026 ()
- Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Island Dental Lab Inc. DBA Emerald Dental Lab
Emerald Herbst
In Commercial Distribution
- DR5032714 ()
- Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Island Dental Lab Inc. DBA Emerald Dental Lab
Emerald Herbst
In Commercial Distribution
- DR4032584 ()
- Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
Expression MRI Patient Vital Signs Monitor, Wireless 2.4 GHz Dual Lead ECG Capable, Wireless 2.4 GHz, Pulse Oximetry (SpO2) Capable, Integrated Non-Invasive Blood Pressure (NIBP), Advanced ECG Filter, Integrated End-Tidal CO2, Active Trend Arrows, 360 Degree Alarm light, Quick Connect Accessories, All parameters support Adult, Pediatric, Infant and Neonatal applications, 8-Hour Smart Battery Technology, One (1) year limited warranty and factory service for hardware, Patient Monitor manufactured by Philips Healthcare and branded for Invivo Corporation, anaffiliate of Philips Healthcare. The Patient Monitor is provided with Invivo's standard 1 year. Warranty,a copy of which is available upon request. Post warranty service may be purchased for the Invivo Patient Monitor at the point of sale. For service after the point-of-sale, please contact. Invivo at 1-877-468-4861 option 1, option 3.
Philips Ds North America LLC
Expression MRI Patient Monitor
Not in Commercial Distribution
- 00884838016064 ()
865214
- General-purpose multi-parameter bedside monitor
The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The
balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
PULMONX CORPORATION
CHR-CO-300
In Commercial Distribution
- 00811907031161 ()
- Diagnostic spirometer, professional
The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
PULMONX CORPORATION
CHR-CO-300
In Commercial Distribution
- 00811907031123 ()
- Diagnostic spirometer, professional
The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system.
The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring.
Medical Device Info.
• Class II (enforcement discretion) medical device
• Regulation: Oximeter, 870.2700
• Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.
All.health, Inc.
Model 1000
In Commercial Distribution
- 00860010157008 ()
ALGO-m1000-SW (rev 0)
- Pulse oximeter
PURE EP™ is a system consists of two main parts: the amplifier,
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
AE-0001-412
Not in Commercial Distribution
- 08567500070008 ()
AE-0001-412
- Cardiac electrophysiology analysis system
PURE EP™ is a system consists of two main parts: the amplifier (aka MSU - Main System Unit),
and the personal computer (PC), which are connected over a highspeed
fiber optic cable. The patient is connected to the amplifier via
a set of supplied ECG cables and commercially available
intracardiac (IC) catheters. The amplifier includes hardware and
embedded software necessary for acquiring ECG and IC signals
from patients. The device is not intended for active patient
monitoring. It consists of one ECG and seven IC modules designed
to acquire 12-lead ECG and 56 IC signals and send the digitized
data to the PC. The PC has preinstalled PURE-EP software and is
connected to display monitors. The pre-installed software provides
visualization of received data from the amplifier on real-time and
review screens. It also includes a signal processing module that
provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
AE-0001-412
In Commercial Distribution
- 00856750007000 ()
PE-002-001-000
- Cardiac electrophysiology analysis system