510(k) K260604 ยท NHJ Device, Positive Pressure Breathing, Intermittent
BiWaze Clear System
| Applicant | Abmrc, LLC, Eagan MN, US |
| Decision | Substantially Equivalent, Aug 24, 2026 |
| Received | Feb 24, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260604
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.