510(k) K242967
K242967 is an FDA 510(k) premarket notification submitted by Fitbit for the device "Loss of Pulse Detection". The FDA issued a decision of Substantially Equivalent on February 25, 2025. The device falls under product code SDY (Loss Of Pulse Notification Software), a Class II device regulated under 21 CFR 870.2790. Fitbit has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2025
- Date Received
- September 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Loss Of Pulse Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2790
- Review Panel
- CV
- Submission Type
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.