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Loss Of Pulse Notification Software

FDA product code SDY · 1 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
2025-02-25 – 2025-02-25

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis.

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