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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 K935186
Device Name ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY
Applicant
Electrophysiology Systems, Inc.
13 Eastbury Ct.
Ann Arbor,  MI  48105
Applicant Contact JANICE M JENKINS
Correspondent
Electrophysiology Systems, Inc.
13 Eastbury Ct.
Ann Arbor,  MI  48105
Correspondent Contact JANICE M JENKINS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/26/1993
Decision Date 01/03/1995
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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