510(k) K094040 ยท BZD Ventilator, Non-Continuous (Respirator)
F&P ICON SERIES CPAP
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, Apr 27, 2010 |
| Received | Dec 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K094040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2013 | Fisher & Paykel Healthcare, Ltd. Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure).
Models:
ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ.
ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ.
ICON Premo: ICONPBN, ICONPB Terminated |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.