510(k) K212372 ยท QDB Photoplethysmograph Analysis Software For Over-The-Counter Use
Fitbit Irregular Rhythm Notifications
| Applicant | Fitbit, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Apr 8, 2022 |
| Received | Jul 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212372
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.