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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K813358
Device Name GERARD MEDICAL ELECTRODE TESTER
Applicant
Gerard Medical Enterprises, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gerard Medical Enterprises, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2370
Classification Product Code
KRC  
Date Received11/30/1981
Decision Date 12/29/1981
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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