510(k) K090243 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, May 8, 2009 |
| Received | Feb 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090243
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.