510(k) K122267

GIRAFFE AND PANDA WARMERS by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. — Product Code FMT

K122267 is an FDA 510(k) premarket notification submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. for the device "GIRAFFE AND PANDA WARMERS". The FDA issued a decision of Substantially Equivalent on October 2, 2012. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohmeda Medical, A Division of Datex-Ohmeda, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2012
Date Received
July 30, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type