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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment With Alarm
510(k) Number K101602
Device Name VITAL SIGNS 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 Number870.1025
Classification Product Code
MLD  
Subsequent Product Code
MHX  
Date Received06/08/2010
Decision Date 09/01/2010
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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