K243778
- 510(k) number
- K243778
- Device name
- Body Temperature Software (BTS)
- Applicant
- Fitbit, LLC CA · US
- Product code
- QZA — Body Temperature Sensing Software
- Decision date
- 2025-02-13
- Date received
- 2024-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243778.pdf
Official FDA record: K243778
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.