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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K884643
Device Name 1100 VITAL SIGNS MONITOR
Applicant
Criticare Systems, Inc.
P.O. Box 26556
Milwaukee,  WI  53226
Applicant Contact DER RUHR
Correspondent
Criticare Systems, Inc.
P.O. Box 26556
Milwaukee,  WI  53226
Correspondent Contact DER RUHR
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/07/1988
Decision Date 10/30/1989
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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