Body Temperature Software (BTS)
FDA 510(k) clearance K243778 · decided 2025-02-13
Clearance details
- K-number
- K243778
- Device name
- Body Temperature Software (BTS)
- Applicant
- Fitbit, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-12-09
- Decision date
- 2025-02-13
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- QZA
- Device class
- 2
- Regulation number
- 880.2915
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Body Temperature Software (BTS) (DEN230050) | Fitbit, LLC | 2023-12-15 |
Recalls involving this device
No recalls on record reference this clearance.