510(k) K021861 ยท BZD Ventilator, Non-Continuous (Respirator)
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jun 19, 2002 |
| Received | Jun 6, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/ Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.