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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K001896
Device Name KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
Original Applicant
SUZUKEN CO., LTD.
55 northern blvd.
suite 200
great neck,  NY  11021
Original Contact carolann kotula
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/21/2000
Decision Date 01/08/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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