Device |
photoplethysmograph analysis software for over-the-counter use |
Regulation Description |
Photoplethysmograph analysis software for over-the-counter use. |
Definition |
A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis. |
Product Code | QDB |
Regulation Number |
870.2790
|
Device Class |
2
|
MDR Year |
MDR Reports |
MDR Events |
2025 |
1 |
1 |
|
|
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