510(k) K072755 ยท BZD Ventilator, Non-Continuous (Respirator)
GALEMED CPAP MASK
| Applicant | Galemed Corp., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Nov 16, 2007 |
| Received | Sep 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072755
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.