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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 K160092
Device Name Digital Electrocardiograph
Applicant
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
#A735,Shenzhen Mingyou Industrial Product
Exhibition & Procurement Center,
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 Received01/15/2016
Decision Date 02/12/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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