The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Panda Ires Warmer, Giraffe Warmer.
| Device ID | K201628 |
| 510k Number | K201628 |
| Device Name: | Panda IRes Warmer, Giraffe Warmer |
| Classification | Warmer, Infant Radiant |
| Applicant | GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Michelle Johnson |
| Correspondent | Michelle Johnson GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2021-02-12 |