510(k) K971461 ยท FMT Warmer, Infant Radiant
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
| Applicant | Fisher & Paykel Electronics , Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jul 16, 1997 |
| Received | Apr 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2014 | Fisher & Paykel Healthcare, Ltd. Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer
Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly
It is designed to assist with the thermoregulation of infan Terminated |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.