510(k) K212516 ยท QDB Photoplethysmograph Analysis Software For Over-The-Counter Use
IRNF App
| Applicant | Apple, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Oct 22, 2021 |
| Received | Aug 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212516
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.