Cleared Traditional

OHMEDA MEDICAL GIRAFFE INCUBATOR

K010222 · Ohmeda Medical · General Hospital
Mar 2001
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K010222 is an FDA 510(k) clearance for the OHMEDA MEDICAL GIRAFFE INCUBATOR, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on March 21, 2001, 56 days after receiving the submission on January 24, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K010222 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2001
Decision Date March 21, 2001
Days to Decision 56 days
Submission Type Traditional
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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