K251663 is an FDA 510(k) clearance for the Giraffe OmniBed Carestation (CS1). This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Datex-Ohmeda, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on October 22, 2025, 145 days after receiving the submission on May 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K251663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | October 22, 2025 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMZ — Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |