Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)— 510(k) K260326
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K260326 for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1), Substantially Equivalent on 2026-07-28. Applicant: Datex-Ohmeda, Inc.. Device class: 2.
Summary
Datex-Ohmeda's clearance covers the Giraffe OmniBed Carestation and the Giraffe Incubator Carestation, both listed as CS1. They're filed under FMZ, neonatal incubators, and the record doesn't say how the two differ.
Class II, 21 CFR 880.5400. General Hospital is both the classification panel and the review panel, and it was a Traditional 510(k).
Datex-Ohmeda filed from Waukesha, Wisconsin. Review took 179 calendar days (January 30 to July 28, 2026).
Clearance details
- Applicant
- Datex-Ohmeda, Inc.
- Product code
- Product code FMZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code FMZ
view allMore clearances from Datex-Ohmeda, Inc.
view allAdverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.