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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 K171517
Device Name Digital Electrocardiograph
Applicant
Biocare Bio-Medical Equipment Co., Ltd.
#16-1, Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan New District
Shenzhen,  CN 518102
Applicant Contact Hongbo Zhong
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/24/2017
Decision Date 01/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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