ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
Basic Information
- Primary DI
- 08806090792045
- Basic UDI-DI Code
- 88060940602706J
- Reference
- 360049
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Samsung Electronics Co., Ltd.
Additional Description
The ECG App is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG for adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm. Identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050382 | ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES |
| Z12040182 | GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES |
| Z12050392 | ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE |
Available In Countries
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The Basic UDI-DI associated with this device has 5 devices in total. Below are some other devices sharing the same Basic UDI-DI.
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DeviceSimilar Devices
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