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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K012059
Device Name 8100/8500 VITAL SIGNS MONITOR
Applicant
Criticare Systems, Inc.
20925 Crossroads Circle
Waukesha,  WI  53186
Applicant Contact ALEX KAPLAN
Correspondent
Criticare Systems, Inc.
20925 Crossroads Circle
Waukesha,  WI  53186
Correspondent Contact ALEX KAPLAN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/02/2001
Decision Date 08/01/2001
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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