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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 K163607
Device Name ECG Acquisition Systems
Applicant
VALES & HILLS BIOMEDICAL TECH. LTD.
No.2 North Street Jingyuan
Beijing Economic-technological Development Aera
beijing,  CN 100176
Applicant Contact jianfang liu
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
NO. 55 Shizhou middle road, Nanshan District
shenzhen,  CN 518000
Correspondent Contact field fu
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/21/2016
Decision Date 12/15/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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