510(k) K241469 ยท BZD Ventilator, Non-Continuous (Respirator)
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Jun 15, 2024 |
| Received | May 24, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241469
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.