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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 K944860
Device Name SCHOLAR 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 Number870.1025
Classification Product Code
MHX  
Date Received10/03/1994
Decision Date 06/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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