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No Description
Sonova AG
088-0021
In Commercial Distribution
- 07613389543254 ()
- Audiometric/hearing device software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution
- 15694311111665 ()
- Sleep disorder interpretive software, professional-only
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution
- 07290018393147 ()
- Configurable electronic form web-based application software
The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider.
The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan.
The Diary Mobile app is suited for both iPhone and Android users.
The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above
the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.
The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.
DREAMED DIABETES LTD
02.XX.YY
In Commercial Distribution
- 07290017735030 ()
N/A
- Clinical management support software
A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera.
It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System.
For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution
- 07290017025094 ()
MAU-EG20004
- Radiology information system application software
Dream Sock Software App.
The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not
intended to provide notification for every episode of the unexpected occurrences of elevated or
depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only
when sufficient data are available for analysis. The notifications and associated data can be used to
supplement the decision by caregivers to seek additional guidance for medical care of the infant. The
Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution
- 00810099090819 ()
- Multiple vital physiological parameter monitoring system, home-use
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution
- 00884838082137 ()
mSafe
- Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution
- 00884838082120 ()
mSafe
- Vulnerable patient home alert system
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution
- B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ.
The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution
- B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software