Cleared Special

MODIFICATION TO: GIRAFFE AND PANDA WARMER

K090697 · Ohmeda Medical · General Hospital
Apr 2009
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K090697 is an FDA 510(k) clearance for the MODIFICATION TO: 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 April 16, 2009, 30 days after receiving the submission on March 17, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K090697 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2009
Decision Date April 16, 2009
Days to Decision 30 days
Submission Type Special
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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