510(k) K063830 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR AFLEX CPAP SYSTEM
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 9, 2007 |
| Received | Dec 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063830
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.