510(k) K201628 ยท FMT Warmer, Infant Radiant
Panda iRes Warmer, Giraffe Warmer
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Feb 12, 2021 |
| Received | Jun 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2026 | Datex-Ohmeda Inc Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with
Integrated Resuscitation System (iRes)
Product Identifiers: M1118179, M1112198
Impacted only if service blender M1091607- Open, Classified |
FMT | None listed |
| Sep 20, 2024 | Wipro GE Healthcare Private Ltd. GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiolo Open, Classified |
FMT | None listed |
| Sep 20, 2024 | Wipro GE Healthcare Private Ltd. GE Panda iRES Warmer, Model/Catalog Numbers:
1) M1112198-01045518;
2) M1112198-01045579;
3) M1112198-01047148;
4) M1112198-01047271;
5) M1112198-01048731;
6) M1112198-01048740;
7) M1112198-010 Open, Classified |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.