510(k) K243778 ยท QZA Body Temperature Sensing Software
Body Temperature Software (BTS)
| Applicant | Fitbit, LLC, San Francisco CA, US |
| Decision | Substantially Equivalent, Feb 13, 2025 |
| Received | Dec 9, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243778
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.