510(k) K092835 ยท BZD Ventilator, Non-Continuous (Respirator)
COMFORTGEL NASAL MASK
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Feb 12, 2010 |
| Received | Sep 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092835
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.