510(k) K243778
K243778 is an FDA 510(k) premarket notification submitted by Fitbit, LLC for the device "Body Temperature Software (BTS)". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code QZA (Body Temperature Sensing Software), a Class II device regulated under 21 CFR 880.2915. Fitbit, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2025
- Date Received
- December 9, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Body Temperature Sensing Software
- Device Class
- Class II
- Regulation Number
- 880.2915
- Review Panel
- HO
- Submission Type
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.