510(k) K072592 ยท BZD Ventilator, Non-Continuous (Respirator)
PERFORMAX TOTAL FACE MASK
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 19, 2007 |
| Received | Sep 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072592
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.