FDA 510(k) Application Details - K162562

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K162562
Device Name	System, Thermal Regulating
Applicant	BCG MEDICAL, LLC 6715 RANCHO TOYON PLACE SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	LISA GIAP Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2016
Decision Date	03/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review