Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)— 510(k) K251663

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K251663 for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1), Substantially Equivalent on 2025-10-22. Applicant: Datex-Ohmeda, Inc..

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2025-05-30
Decision date: 2025-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.