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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 K861099
Device Name GEREONICS BIOPOTENTIAL SKIN ELECTRODES
Applicant
Gereonics, Inc.
P.O. Box 805
Escondido,  CA  92025
Applicant Contact GERALD A ROST
Correspondent
Gereonics, Inc.
P.O. Box 805
Escondido,  CA  92025
Correspondent Contact GERALD A ROST
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/24/1986
Decision Date 08/06/1986
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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