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The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTAHA0 ()
- Electrocardiograph, professional, multichannel
VIDEOSTAR I is a monocular videonystagmoscope device. It transcribes the image of the patient's eye on the computer screen. It helps to asses the reaction of the patient viewing his eye and its nystagmus during testing. The device consists of a goggle that set the camera in front of the patient's eye and allows to occult the patient of the outside, a camera with an infrared lighting and a software running on a computer. The camera is place of the left or the right eye, the other one can either be let free or cover to deny patient's view.
Instrumentation Difra SA
VIDEOSTAR
In Commercial Distribution
- B516220900 ()
22090
- Posturography system platform
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution
- B322D0011 ()
- Pulse oximeter, line-powered
The Heidelberg pH Capsule system is an assembly of devices designed to continuously monitor, measures and transmit information from the gastric and gastrointestinal systems. The transmitted gastric and gastrointestinal parameters from the pH Capsule are (i.e., pH or events), (e.g., gastric bleeding). The information from the pH capsule is received by the transceiver and then sent through the interface and to the computer. The computer software analyzes the information and displays it on a generated graph. The system assembly includes various solutions, test tubes, fluid containers and pH capsule calibration test fixture. The Heidelberg pH Capsule System is intended to help diagnose varies gastric and gastrointestinal pH related disorders.
Heidelberg Medical Inc
Heidelberg pH Capsule System
In Commercial Distribution
- B989HPHDS180 ()
HPHDS18
- Gastrointestinal telemetric monitoring system
Curve Image™ is a cloud-based dental image acquisition and management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.
Curve Dental Ltd
CURVE-IMAGE-I
In Commercial Distribution
- D848CURVEIMAGE0 ()
- Radiology picture archiving and communication system workstation
Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actions
performed and the user prompts.
The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
Spectral Medical Inc
84007
In Commercial Distribution
- B173840070 ()
- Not Applicable
84007
- Multiple clinical chemistry analyser IVD, laboratory
The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device with an ice/water backup system along with battery back-up power. These systems allow for transport or remote monitoring if customers decide this is necessary. Donor paperwork and typing materials, biopsy slides, and other specimens can be transported securely with the kidney using the system. The system provides optimal preservation while increasing the user’s ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation.
WATERS MEDICAL SYSTEMS, LLC
WAVES CONTROL UNIT
Not in Commercial Distribution
- B154W39000420000 ()
3900042.000
- Kidney donor-organ preservation/transport perfusion set
The Advance EXPMT 2000 pacemaker analyzer is an advanced microprocessor based test instrument designed to accurately measure the output parameters of all external pacemakers, including both transthoracic and transcutaneous devices with recent upgrade to the software version .The instrument is easy to use via the menu structure presented on a large four line LCD display. Resulting measurements of the tests performed are simultaneously shown on the LCD display. The Advance EXPMT 2000 is compact, lightweight, and rugged. It may be operated with one 9 volt battery or with an optional AC adapter. A standard RS232 serial port allows for printing and storage of results with optional printers and PDAs.
NETECH CORPORATION
Advance EXPMT 2000
In Commercial Distribution
- B33596020000 ()
960-2000
- External pacemaker analyser
The SAMI RRT Unit is a software controlled device that performs the following functions:
- Primes the disposable cassette automatically,
- Pumps blood through the blood flow path of the disposable cassette,
- Delivers anticoagulant into the blood flow path,
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,
- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,
- Controls the patient fluid removal or plasma loss according to the therapy in use,
- Monitors the system and alerts the operator of abnormal situations through alarms.
The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Dialco Medical Inc
SM-100-003
In Commercial Distribution
- B815SM1000030 ()
SM-100-003
- Haemodialysis system, institutional
The SAMI RRT Unit is a software controlled device that performs the following functions:
- Primes the disposable cassette automatically,
- Pumps blood through the blood flow path of the disposable cassette,
- Delivers anticoagulant into the blood flow path,
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,
- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,
- Controls the patient fluid removal or plasma loss according to the therapy in use,
- Monitors the system and alerts the operator of abnormal situations through alarms.
The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Dialco Medical Inc
SA-100-01
In Commercial Distribution
- B815SA100010 ()
SA-100-01
- Haemodialysis system, institutional