510(k) K191912 ยท NHJ Device, Positive Pressure Breathing, Intermittent
BiWaze Cough
| Applicant | Abmrc, LLC, Charleston SC, US |
| Decision | Substantially Equivalent, Mar 27, 2020 |
| Received | Jul 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191912
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.