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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K073709
Device Name MODIFICATION TO VIEWMATE SYSTEM
Applicant
Ep Medsystems
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Applicant Contact LARRY PICCIANO
Correspondent
Ep Medsystems
Cooper Run Executive Park
575 Rte. 73 N., Bldg. D
West Berlin,  NJ  08091
Correspondent Contact LARRY PICCIANO
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received12/31/2007
Decision Date 03/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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