The following data is part of a premarket notification filed by Datex Ohmeda Inc. with the FDA for Giraffe Omnibed Carestation Cs1.
| Device ID | K213551 |
| 510k Number | K213551 |
| Device Name: | Giraffe Omnibed Carestation CS1 |
| Classification | Warmer, Infant Radiant |
| Applicant | Datex Ohmeda Inc. 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Shiwani Zalpuri |
| Correspondent | Shiwani Zalpuri Datex Ohmeda Inc. 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 | 2021-11-08 |
| Decision Date | 2022-03-02 |