Cleared Traditional

OHMEDA MEDICAL GIRAFFE INCUBATOR

K020547 · Ohmeda Medical · General Hospital
May 2002
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K020547 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 May 9, 2002, 79 days after receiving the submission on February 19, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K020547 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2002
Decision Date May 09, 2002
Days to Decision 79 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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