FDA 510(k) Application Details - K011859

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K011859
Device Name	System, Thermal Regulating
Applicant	KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH 1380 LEAD HILL BOULEVARD SUITE 106 ROSEVILLE, CA 95661 US Other 510(k) Applications for this Company
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	06/14/2001
Decision Date	05/01/2002
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