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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Biopotential
510(k) Number K911935
Device Name CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
Applicant
Gould, Inc.
8333 Rockside Rd.
Valley View,  OH  44125
Applicant Contact ROBERT J DUGAN
Correspondent
Gould, Inc.
8333 Rockside Rd.
Valley View,  OH  44125
Correspondent Contact ROBERT J DUGAN
Regulation Number870.2050
Classification Product Code
DRR  
Date Received05/01/1991
Decision Date 07/22/1991
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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