510(k) K133769 ยท BZD Ventilator, Non-Continuous (Respirator)
3B RESMART BPAP 25A, BMC RESMART BPAP 25A
| Applicant | 3B Medical, Inc., Lake Wales FL, US |
| Decision | Substantially Equivalent, Aug 25, 2014 |
| Received | Dec 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133769
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.