Body Temperature Sensing Software
FDA product code QZA · Class II (moderate risk) · 21 CFR 880.2915 · General Hospital
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243778 | Body Temperature Software (BTS)QZA · Special | Fitbit, LLC | 02/13/2025SE |