FDA 510(k) Application Details - K100071

Device Classification Name	Hyperthermia Monitor   More FDA Info for this Device
510(K) Number	K100071
Device Name	Hyperthermia Monitor
Applicant	EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG BRUCKNERSTRASSE 6/7A 1040 WIEN VIENNA 1040 AT Other 510(k) Applications for this Company
Contact	MICHAEL KUEHLING Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	NZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2010
Decision Date	10/12/2010
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	Y
Expedited Review