Body Temperature Software (BTS)— 510(k) K243778
Substantially EquivalentFitbit, LLC
FDA 510(k) clearance K243778 for Body Temperature Software (BTS), Substantially Equivalent on 2025-02-13. Applicant: Fitbit, LLC. Device class: 2.
Clearance details
- Applicant
- Fitbit, LLC
- Product code
- Code QZA
- Device class
- Class 2
- Regulation
- 21 CFR 880.2915
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Francisco, CA, US
Recent devices under product code QZA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.