MODIFICATION TO: GIRAFFE AND PANDA WARMER

Warmer, Infant Radiant

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Modification To: Giraffe And Panda Warmer.

Pre-market Notification Details

Device IDK090697
510k NumberK090697
Device Name:MODIFICATION TO: GIRAFFE AND PANDA WARMER
ClassificationWarmer, Infant Radiant
Applicant OHMEDA MEDICAL 8880 GORMAN RD. Laurel,  MD  20723
ContactAgata Smieja
CorrespondentAgata Smieja
OHMEDA MEDICAL 8880 GORMAN RD. Laurel,  MD  20723
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-17
Decision Date2009-04-16
Summary:summary

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