DEN230050
- 510(k) number
- DEN230050
- Device name
- Body Temperature Software (BTS)
- Applicant
- Fitbit, LLC CA · US
- Product code
- QZA — Body Temperature Sensing Software
- Decision date
- 2023-12-15
- Date received
- 2023-07-17
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN230050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.