Cleared Special

MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)

K072157 · Ohmeda Medical · General Hospital

Aug 2007

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K072157 is an FDA 510(k) clearance for the MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY), a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on August 27, 2007, 24 days after receiving the submission on August 3, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number	K072157 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2007
Decision Date	August 27, 2007
Days to Decision	24 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF