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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
510(k) Number K935590
Device Name EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
Applicant
Ep Medical, Inc.
58 Rte. 46 W.
Budd Lake,  NJ  07828
Applicant Contact DAVID A JENKINS
Correspondent
Ep Medical, Inc.
58 Rte. 46 W.
Budd Lake,  NJ  07828
Correspondent Contact DAVID A JENKINS
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received11/18/1993
Decision Date 05/05/1994
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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