SDY — Loss Of Pulse Notification Software Class II
FDA product code SDY covers "Loss Of Pulse Notification Software", a Class II medical device regulated under 21 CFR 870.2790. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SDY
- Device Class
- Class II
- Regulation Number
- 870.2790
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242967 | fitbit | Loss of Pulse Detection | February 25, 2025 |