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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 K925346
Device Name EP AMP, MODEL #901
Applicant
Quinton Electrophysiology Corp.
3075 14th Ave., Suite 6
Markham, Ontario,  CA L3R 2L6
Applicant Contact HAROLD WODLINGER
Correspondent
Quinton Electrophysiology Corp.
3075 14th Ave., Suite 6
Markham, Ontario,  CA L3R 2L6
Correspondent Contact HAROLD WODLINGER
Regulation Number870.2050
Classification Product Code
DRR  
Date Received10/22/1992
Decision Date 04/30/1993
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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