FDA 510(k) Application Details - K201628

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K201628
Device Name	Warmer, Infant Radiant
Applicant	GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Michelle Johnson Other 510(k) Applications for this Contact
Regulation Number	880.5130   More FDA Info for this Regulation Number
Classification Product Code	FMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2020
Decision Date	02/12/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review