510(k) K251770 ยท BZD Ventilator, Non-Continuous (Respirator)
SleepRes PAP System
| Applicant | Sleepres, Inc., Murfreesboro TN, US |
| Decision | Substantially Equivalent, Dec 15, 2025 |
| Received | Jun 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251770
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.