510(k) K222597 ยท DQA Oximeter
BabySat 3
| Applicant | Owlet Babycare, Inc., Lehi UT, US |
| Decision | Substantially Equivalent, Jun 16, 2023 |
| Received | Aug 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222597
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.