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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 K142489
Device Name Unimed Disposable ECG lead wires
Applicant
UNIMED MEDICAL SUPPLIES INC.
NO.37, YANSHAN ROAD, SHEKOU
SHENZHEN,  CN 518067
Applicant Contact Tan Xinmei
Correspondent
UNIMED MEDICAL SUPPLIES INC.
NO.37, YANSHAN ROAD, SHEKOU
SHENZHEN,  CN 518067
Correspondent Contact Tan Xinmei
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/04/2014
Decision Date 11/04/2014
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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