FDA 510(k) Application Details - K173516

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K173516
Device Name	Warmer, Infant Radiant
Applicant	International Biomedical 8206 Cross Park Drive Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	Amy Pieper 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	11/14/2017
Decision Date	08/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review