510(k) K123309

GIRAFFE AND PANDA WARMERS by Ohmeda Medical — Product Code FMT

K123309 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "GIRAFFE AND PANDA WARMERS". The FDA issued a decision of Substantially Equivalent on February 5, 2013. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohmeda Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2013
Date Received
October 24, 2012
Clearance Type
Traditional
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