510(k) K203601 ยท BZD Ventilator, Non-Continuous (Respirator)
Innova Nasal Non-Vented Mask
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Apr 30, 2021 |
| Received | Dec 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203601
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.