510(k) K241830 ยท BZD Ventilator, Non-Continuous (Respirator)
Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Oct 18, 2024 |
| Received | Jun 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241830
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.