510(k) K050759 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP AUTO
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jun 15, 2005 |
| Received | Mar 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.