Cleared Special

GIRAFFE OMNIBED

K101788 · Ohmeda Medical · General Hospital
Jul 2010
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K101788 is an FDA 510(k) clearance for the GIRAFFE OMNIBED, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on July 21, 2010, 26 days after receiving the submission on June 25, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K101788 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2010
Decision Date July 21, 2010
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMZ — Incubator, Neonatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5400

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