FDA 510(k) Application Details - K101602

Device Classification Name	Monitor, St Segment With Alarm   More FDA Info for this Device
510(K) Number	K101602
Device Name	Monitor, St Segment With Alarm
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	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MLD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2010
Decision Date	09/01/2010
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