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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 K001020
Device Name 8100 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 Number870.2300
Classification Product Code
MWI  
Date Received03/30/2000
Decision Date 04/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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