QZA
- Product code
- QZA
- Device name
- Body Temperature Sensing Software
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.2915
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243778 | 2025-02-13 | Fitbit, LLC | Body Temperature Software (BTS) | |
| DEN230050 | 2023-12-15 | Fitbit, LLC | Body Temperature Software (BTS) | — |
Official FDA classification page: QZA
Classification and pathway per current FDA publications. Data from openFDA (CC0).