510(k) K131901 ยท BZD Ventilator, Non-Continuous (Respirator)
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
| Applicant | 3B Medical, Inc., Lake Wales FL, US |
| Decision | Substantially Equivalent, Dec 23, 2013 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131901
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.