FDA Product Code
FDA Product Code QZA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2915
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243778 | Body Temperature Software (BTS) | Fitbit, LLC | 2025-02-13 | Special | PDF ↗ |
| DEN230050 | Body Temperature Software (BTS) | Fitbit, LLC | 2023-12-15 | Direct | — |
Product code QZA · Class II · General Hospital. Data: openFDA.