OHMEDA MEDICAL GIRAFFE OMNIBED— 510(k) K071175

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K071175 for OHMEDA MEDICAL GIRAFFE OMNIBED, Substantially Equivalent on 2007-07-17. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2007-04-27
Decision date: 2007-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Laurel, MD, 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.