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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
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution
- 15694311111665 ()
- Sleep disorder interpretive software, professional-only
SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution
- 00721902865572 ()
- Multi-purpose stereotactic surgery system
APP,KS CHOICE,3.2.2,ANDR
Gn Hearing A/S
20425500
In Commercial Distribution
- 05708296076703 ()
- Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution
- 05708296076697 ()
- Hearing aid/implant system remote control
APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
In Commercial Distribution
- 05708296074259 ()
- Hearing aid/implant system remote control
APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution
- 05708296074242 ()
- Hearing aid/implant system remote control
APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
In Commercial Distribution
- 05708296074235 ()
- Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution
- 05708296074228 ()
- Hearing aid/implant system remote control
APP,RS SMART,3.4,ANDR
Gn Hearing A/S
20416600
In Commercial Distribution
- 05708296074211 ()
- Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution
- 05708296074204 ()
- Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution
- 05708296071548 ()
- Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution
- 05708296071531 ()
- Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution
- 05708296070831 ()
- Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution
- 05708296070824 ()
- Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution
- 05708296070817 ()
- Hearing aid/implant system remote control
APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution
- 05706069779714 ()
21035228
- Hearing aid/implant system remote control
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution
- 05706069779707 ()
21035227
- Hearing aid/implant system remote control
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution
- 05706069674729 ()
5 300 0007 001
- Tinnitus masking application software
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution
- 05706069674712 ()
5 300 0006 001
- Tinnitus masking application software
BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution
- 05706069673579 ()
5 300 0005 001
- Hearing aid/implant system remote control
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution
- 05706069673562 ()
5 300 0004 001
- Hearing aid/implant system remote control
BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution
- 00851203006272 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution
- 00851203006265 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution
- 00851203006258 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution
- 00851203006241 ()
- Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution
- 00851203006234 ()
- Wireless patient monitor/sensor reporting software, layperson-use
J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution
- 05690977308701 ()
JT-115
- Traction system skull tongs
APP,AUDIGY ATTUNE,1.2,ANDR
Gn Hearing A/S
20789100
In Commercial Distribution
- 05708296097258 ()
- Hearing aid/implant system remote control
APP,AUDIGY ATTUNE,1.2,IOS
Gn Hearing A/S
20789000
In Commercial Distribution
- 05708296097241 ()
- Hearing aid/implant system remote control