510(k) K243861 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
butterflyBVM
| Applicant | Compact Medical, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Dec 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243861
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.