FDA 510(k) Application Details - K091050

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K091050
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate 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	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2009
Decision Date	05/27/2009
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