510(k) K011714 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP PRO BI-LEVEL SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jun 28, 2001 |
| Received | Jun 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011714
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /P Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.