510(k) K153387 ยท BZD Ventilator, Non-Continuous (Respirator)
Luna CPAP and Auto CPAP System
| Applicant | 3B Medical, Inc., Lake Wales FL, US |
| Decision | Substantially Equivalent, Sep 8, 2016 |
| Received | Nov 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153387
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.