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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K032225
Device Name EP-WORKMATE WITH RPM SYSTEM
Applicant
Ep Medsystems
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact JAMES E KUHN
Correspondent
Ep Medsystems
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact JAMES E KUHN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/21/2003
Decision Date 08/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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