FDA 510(k) Application Details - K102900

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K102900
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	HEI, INC. 4801 NORTH 63RD. ST. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	GREGORY MATHISON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2010
Decision Date	03/21/2012
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