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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K091050
Device Name 506CN PATIENT MONITOR
Applicant
Criticare Systems, Inc.
20925 Crossroads Cir.
Waukesha,  WI  53186
Applicant Contact ALEX KAPLAN
Correspondent
Criticare Systems, Inc.
20925 Crossroads Cir.
Waukesha,  WI  53186
Correspondent Contact ALEX KAPLAN
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Code
DQA  
Date Received04/13/2009
Decision Date 05/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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