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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(with arrhythmia detection or alarms)
510(k) Number K030613
Device Name VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
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 Number870.1025
Classification Product Code
MHX  
Date Received02/26/2003
Decision Date 04/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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