Garmin ECG App
Basic Information
- Primary DI
- 00860009117709
- Basic UDI-DI Code
- 0860009117709SS
- Reference
- Smartphone ECG App Component
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Garmin International, Inc.
Additional Description
The Garmin ECG app is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to create, record, store, transfer, and display a single-channel electrocardiograph similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm(SR) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is not intended for use by people under 22 years old.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050392 | ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE |
Available In Countries
Related Devices
The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).