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No Description
Thought Technology Ltd.
SA4502
In Commercial Distribution
- 07540191000487 ()
- Psychophysiological biofeedback system
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution
- 25060753520070 ()
- Video otoscope/audiometer
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is
intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
Fitbit LLC
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software, professional-only
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
- 00810099090826 ()
- Multiple vital physiological parameter monitoring system, home-use
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 Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution
- B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP
- Electrocardiographic long-term ambulatory recording analyser application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution
- 00619498000722 ()
31302
- Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution
- 00619498313020 ()
31302
- Ventilator application software
DreamMapper Web China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution
- 00606959058996 ()
1136946
- Self-care monitoring/reporting software
DreamMapper Web EU instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution
- 00606959058972 ()
1128262
- Self-care monitoring/reporting software