510(k) K131707 ยท BZD Ventilator, Non-Continuous (Respirator)
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
| Applicant | 3B Medical, Inc., Lake Wales FL, US |
| Decision | Substantially Equivalent, Aug 22, 2013 |
| Received | Jun 11, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131707
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.