510(k) K253939 ยท BZD Ventilator, Non-Continuous (Respirator)
DeltaWave Nasal Pillow System
| Applicant | RemSleep Holdings, Inc., Blackshear GA, US |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Dec 9, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253939
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.