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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 K871626
Device Name ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
Applicant
Jason Marketing Co.
5142 Argosy Dr.
Huntington Beach,  CA  92649
Applicant Contact JAY RUEHLEN
Correspondent
Jason Marketing Co.
5142 Argosy Dr.
Huntington Beach,  CA  92649
Correspondent Contact JAY RUEHLEN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/27/1987
Decision Date 06/05/1987
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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