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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K101024
Device Name KENZ CARDY302 MAX
Applicant
Suzuken Co., Ltd.
1201 Richardson
Suite 280
Richardson,  TX  75080
Applicant Contact LINDA MORGAN
Correspondent
Suzuken Co., Ltd.
1201 Richardson
Suite 280
Richardson,  TX  75080
Correspondent Contact LINDA MORGAN
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/13/2010
Decision Date 01/06/2011
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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