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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 K092913
Device Name EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
Applicant
Ep Medsystems
575 Rt. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact SUSHMA RAO
Correspondent
Ep Medsystems
575 Rt. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact SUSHMA RAO
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received09/22/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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