Panda IRes Warmer, Giraffe Warmer

Warmer, Infant Radiant

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Panda Ires Warmer, Giraffe Warmer.

Pre-market Notification Details

Device IDK201628
510k NumberK201628
Device Name:Panda IRes Warmer, Giraffe Warmer
ClassificationWarmer, Infant Radiant
Applicant GE Healthcare 9900 Innovation Drive Wauwatosa,  WI  53226
ContactMichelle Johnson
CorrespondentMichelle Johnson
GE Healthcare 9900 Innovation Drive Wauwatosa,  WI  53226
Product CodeFMT  
CFR Regulation Number880.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2021-02-12

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.