SDY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Loss Of Pulse Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2790
- Medical specialty
- Cardiovascular
- FDA definition
- 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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| Record | Firm | Date |
|---|---|---|
| Loss of Pulse Detection (K242967) | Fitbit | 2025-02-25 |
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