510(k) K251847 ยท BZD Ventilator, Non-Continuous (Respirator)
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Jan 15, 2026 |
| Received | Jun 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251847
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.