510(k) K003335 ยท FMT Warmer, Infant Radiant
RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
| Applicant | Hill-Rom Air-Shields, Hatboro PA, US |
| Decision | Substantially Equivalent, Nov 17, 2000 |
| Received | Oct 25, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2009 | Draeger Medical Systems, Inc. Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only. Terminated |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.