510(k) K233415 ยท BZD Ventilator, Non-Continuous (Respirator)
DELTAWAVE Nasal Pillows System
| Applicant | Remsleep Holdings, Clearwater FL, US |
| Decision | Substantially Equivalent, Jul 2, 2024 |
| Received | Oct 10, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233415
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.