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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 K133985
Device Name DIGITAL ELECTROCARDIOGRAPH
Applicant
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
P.O. BOX 120-119
shanghai,  CN 200120
Applicant Contact diana hong
Correspondent
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
P.O. BOX 120-119
shanghai,  CN 200120
Correspondent Contact diana hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/26/2013
Decision Date 01/22/2015
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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