PulseOn Arrhythmia Monitor System
Basic Information
- Primary DI
- 06430054330206
- Basic UDI-DI Code
- 643005433AMSD4
- Reference
- AMS-1
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- PulseOn Oy
Additional Description
The PulseOn Arrhythmia Monitor System is used to assist in the diagnosis, screening and monitoring of atrial fibrillation and other cardiac arrhythmias visible in Lead I ECG. The system consists of a wrist-worn device and a data management service. The wrist device optically monitors pulse rate during periods of no motion, in order to detect possible atrial fibrillation, and it is used to take intermittent single-lead electrocardiogram (ECG) measurements between the arms. The wrist device stores the measured data, which is later transferred to the data management service where the data can be analysed by medical professionals. The device is intended to be used inside or outside a hospital environment. The usage period of the system can vary from days to several weeks.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C020599 | CARDIAC DIAGNOSTIC DEVICES - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).