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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K964803
Device Name UNIVISION ECHOCARDIOLOGY SYSTEM
Applicant
Network Concepts, Inc.
2135 W. Greenview Dr.
Middleton,  WI  53562
Applicant Contact LARRY SIEB
Correspondent
Network Concepts, Inc.
2135 W. Greenview Dr.
Middleton,  WI  53562
Correspondent Contact LARRY SIEB
Regulation Number892.2010
Classification Product Code
LMB  
Date Received11/29/1996
Decision Date 02/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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