Loss Of Pulse Notification Software
FDA product code SDY · Class II (moderate risk) · 21 CFR 870.2790 · Cardiovascular
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.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242967 | Loss of Pulse DetectionSDY · Traditional | Fitbit | 02/25/2025SE |