FDA 510(k) Application Details - K123946

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K123946
Device Name	System, Thermal Regulating
Applicant	CINCINNATI SUB-ZERO PRODUCTS, INC 12011 MOSTELLER ROAD CINCINNATI, OH 45241-1528 US Other 510(k) Applications for this Company
Contact	STEVEN J BERKE 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	12/21/2012
Decision Date	01/17/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review