510(k) K241661 ยท BZD Ventilator, Non-Continuous (Respirator)
Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Jul 10, 2024 |
| Received | Jun 10, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241661
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.