510(k) K963058 ยท FMT Warmer, Infant Radiant
INFANT WARMER SYSTEM
| Applicant | Ohmeda Medical, Columbia MD, US |
| Decision | Substantially Equivalent, Oct 1, 1996 |
| Received | Aug 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | GE Healthcare, LLC Infant Warmer System (IWS) Terminated |
FMT | None listed |
| Nov 18, 2016 | Ohmeda Medical IWS
Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat t Terminated |
FMT | None listed |
| Aug 4, 2016 | GE Healthcare, LLC Infant Warmer System (IWS) Terminated |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.