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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K870834
Device Name TDK ECG ELECTRODE MEL-10
Applicant
Tdk Corp.
2-15-7, Higashi-Owada
Ichikawa-Shi, Chiba
272 01, Japan,  JP
Correspondent
Tdk Corp.
2-15-7, Higashi-Owada
Ichikawa-Shi, Chiba
272 01, Japan,  JP
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/03/1987
Decision Date 03/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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