FDA 510(k) Application Details - K961223

Device Classification Name	System, Ecg Analysis   More FDA Info for this Device
510(K) Number	K961223
Device Name	System, Ecg Analysis
Applicant	CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE WAUKESHA, WI 53186 US Other 510(k) Applications for this Company
Contact	ALEX KAPLAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/1996
Decision Date	12/10/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review