510(k) K082558 ยท BZD Ventilator, Non-Continuous (Respirator)
COMFORTLITE NASAL MASK
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 25, 2009 |
| Received | Sep 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082558
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.