Cleared Traditional

GIRAFFE AND PANDA WARMERS

K123309 · Ohmeda Medical · General Hospital
Feb 2013
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K123309 is an FDA 510(k) clearance for the GIRAFFE AND PANDA WARMERS, a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on February 5, 2013, 104 days after receiving the submission on October 24, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K123309 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2012
Decision Date February 05, 2013
Days to Decision 104 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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