QZA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Body Temperature Sensing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2915
- Medical specialty
- General Hospital
- FDA definition
- Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
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| Record | Firm | Date |
|---|---|---|
| Body Temperature Software (BTS) (K243778) | Fitbit, LLC | 2025-02-13 |
| Body Temperature Software (BTS) (DEN230050) | Fitbit, LLC | 2023-12-15 |
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