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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 K172068
Device Name Kenz Cardico1211
Applicant
Suzuken Co., Ltd.
8 Higashikataha-Machi, Higashi-Ku
Nagoya,  JP 461-0015
Applicant Contact Eiji Yamaguchi
Correspondent
Z&B Enterprises, Inc.
12154 Darnestown Rd., #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/07/2017
Decision Date 06/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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