Cleared Traditional

GIRAFFE AND PANDA WARMER

K070377 · Ohmeda Medical · General Hospital
Jul 2007
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K070377 is an FDA 510(k) clearance for the GIRAFFE AND PANDA WARMER, a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on July 11, 2007, 153 days after receiving the submission on February 8, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K070377 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2007
Decision Date July 11, 2007
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMT — Warmer, Infant Radiant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5130

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