510(k) K122267 ยท FMT Warmer, Infant Radiant
GIRAFFE AND PANDA WARMERS
| Applicant | Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Laurel MD, US |
| Decision | Substantially Equivalent, Oct 2, 2012 |
| Received | Jul 30, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2018 | GE Healthcare, LLC Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer. Terminated |
FMT | None listed |
| Sep 25, 2018 | GE Healthcare, LLC Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer. Terminated |
FMT | None listed |
| Sep 25, 2018 | GE Healthcare, LLC Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer. Terminated |
FMT | None listed |
| Sep 25, 2018 | GE Healthcare, LLC Panda Wall Mount warmer. Infant radiant warmer Terminated |
FMT | None listed |
| May 6, 2014 | GE Healthcare Giraffe Infant Warmers integrated with Nellcor SpO2.
Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for c Terminated |
FMT | None listed |
| May 6, 2014 | GE Healthcare Panda iRes Infant Warmers integrated with Nellcor SpO2.
Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used fo Terminated |
FMT | None listed |
| May 6, 2014 | GE Healthcare Panda Freestanding Infant Warmers, integrated with Nellcor SpO2.
Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring featur Terminated |
FMT | None listed |
| May 6, 2014 | GE Healthcare Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2.
Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature Terminated |
FMT | None listed |
| Feb 25, 2014 | GE Healthcare, LLC GE Healthcare - Giraffe and Panda iRes Infant Warmer
Product Usage:
The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on the Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.