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Photoplethysmograph Analysis Software For Over-The-Counter Use

FDA product code QDB · 4 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2790
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-10-22 – 2023-07-21

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.

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