510(k) K212905 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Sotair Device
| Applicant | Safe Bvm Corporation, Chesterfield MO, US |
| Decision | Substantially Equivalent, Aug 18, 2022 |
| Received | Sep 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212905
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.