510(k) K211274 ยท BZD Ventilator, Non-Continuous (Respirator)
iQ 2 Nasal Mask, Phantom 2 Nasal Mask
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Jan 10, 2022 |
| Received | Apr 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2024 | SleepNet Corporation iQ 2 Nasal Vented Mask Open, Classified |
BZD | None listed |
| Apr 1, 2024 | SleepNet Corporation Phantom 2 Nasal Vented Mask Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.