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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 K152384
FOIA Releasable 510(k) K152384
Device Name Digital Electrocardiograph
Applicant
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
Room A735, Floor 7,Tower A, No.168 Baoyuan Road, Baoan
shenzhen,  CN 519102
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 Received08/24/2015
Decision Date 12/18/2015
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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