510(k) K251574 ยท LEL Device, Sleep Assessment
Sleep Watch
| Applicant | Ambulatory Monitoring, Inc., Ardsley NY, US |
| Decision | Substantially Equivalent, Jul 31, 2025 |
| Received | May 22, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251574
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.