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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 K843731
Device Name KENZ 80Z MARK II
Applicant
Suzuken Co., Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Suzuken Co., Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/24/1984
Decision Date 07/11/1985
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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