DeviceClearance

GIRAFFE OMNIBED— 510(k) K101788

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K101788 for GIRAFFE OMNIBED, Substantially Equivalent on 2010-07-21. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant
Ohmeda Medical
Product code
Code FMZ
Device class
Class 2
Regulation
21 CFR 880.5400
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Laurel, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse 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 →

Recalls naming K101788

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101788.

Data sourced from openFDA. This site is unofficial and independent of the FDA.