510(k) K092648 ยท CBK Ventilator, Continuous, Facility Use
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 18, 2009 |
| Received | Aug 28, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092648
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.