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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
DIA IMAGING ANALYSIS LTD
Lvivo_UI
In Commercial Distribution
- 07290019352037 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Seamless
In Commercial Distribution
- 07290019352020 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Mobile
In Commercial Distribution
- 07290019352013 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Platform
In Commercial Distribution
- 07290019352006 ()
- Ultrasound imaging system application software
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution
- 17540262150018 ()
- Radiological PACS software
SW B36104S SURETUNE4 DBS SERVER
MEDTRONIC, INC.
B36104S
In Commercial Distribution
- 00763000421212 ()
- 00763000496456 ()
- Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT
MEDTRONIC, INC.
B36104C
In Commercial Distribution
- 00763000421212 ()
- 00763000496449 ()
- Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE
MEDTRONIC, INC.
B36104A
In Commercial Distribution
- 00763000421212 ()
- 00763000496432 ()
- Implantable electrical stimulation device management software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.5.y.z
In Commercial Distribution
- 07290018052280 ()
- Radiology DICOM image processing application software