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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K153188
Device Name Caremed patient cable and leadwires
Applicant
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA,
LONGHUA OFFICE, LONGHUA NEW D
SHENZHEN,  CN 518021
Applicant Contact XINLIN XIAO
Correspondent
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA,
LONGHUA OFFICE, LONGHUA NEW D
SHENZHEN,  CN 518021
Correspondent Contact XINLIN XIAO
Regulation Number870.2900
Classification Product Code
DSA  
Date Received11/03/2015
Decision Date 10/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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