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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 K852177
Device Name FOAM ECG ELECTRODES
Applicant
Clinical Data, Inc.
Box 430
Brookline,  MA  02146
Applicant Contact ISRAEL M STEIN
Correspondent
Clinical Data, Inc.
Box 430
Brookline,  MA  02146
Correspondent Contact ISRAEL M STEIN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/20/1985
Decision Date 08/09/1985
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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