510(k) DEN220091 ยท QYU Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Dream Sock
| Applicant | Owlet Babycare, Inc., Lehi UT, US |
| Decision | Unknown, Nov 8, 2023 |
| Received | Dec 14, 2022 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN220091
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.