K251663
- 510(k) number
- K251663
- Device name
- Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- Applicant
- Datex-Ohmeda, Inc. WI · US
- Product code
- FMZ — Incubator, Neonatal
- Decision date
- 2025-10-22
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251663.pdf
Official FDA record: K251663
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.