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DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049932 ()
1101478
- Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049086 ()
1101478
- Self-care monitoring/reporting software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution
- 09321502078962 ()
P1646054
- Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution
- 09321502078955 ()
P1646035
- Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution
- 09321502053006 ()
P1646035
- Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution
- 09321502052993 ()
P1646054
- Audiometric/hearing device software
No Description
Brainlab AG
1.2
In Commercial Distribution
- 04056481145385 ()
- Multidisciplinary medical image management software
No Description
Brainlab AG
1.1
Not in Commercial Distribution
- 04056481144265 ()
- Multidisciplinary medical image management software
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution
- 03701311501497 ()
- Robotic surgical navigation system application software
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, INC.
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software