510(k) K073600 ยท BZD Ventilator, Non-Continuous (Respirator)
COMFORTGEL FULL FACE MASK
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Apr 25, 2008 |
| Received | Dec 21, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073600
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.