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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 K120010
Device Name CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
Industrial Hua Wang
Rd Dalang Longhua Dist
Shenzhen, Guangdong,  CN 518109
Applicant Contact MAOLIN YE
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact BHAVESH V SHETH
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/03/2012
Decision Date 01/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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