510(k) K000994 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP DUET LX BI-LEVEL SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jun 22, 2000 |
| Received | Mar 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000994
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. RP Duet LX/Pro Out Port w/Seal model number 622239. 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.