510(k) K213564 ยท NHJ Device, Positive Pressure Breathing, Intermittent
BiWaze Clear System
| Applicant | Abmrc, LLC, Eagan MN, US |
| Decision | Substantially Equivalent, Dec 21, 2022 |
| Received | Nov 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213564
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.