Loss of Pulse Detection— 510(k) K242967
Substantially EquivalentFitbit
FDA 510(k) clearance K242967 for Loss of Pulse Detection, Substantially Equivalent on 2025-02-25. Applicant: Fitbit. Device class: 2.
Clearance details
- Applicant
- Fitbit
- Product code
- Code SDY
- Device class
- Class 2
- Regulation
- 21 CFR 870.2790
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.