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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K040041
Device Name NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
Applicant
Barco NV Barcoview
12200 Academy Rd. NE, # 931
Albuquerque,  NM  87111
Applicant Contact FRANK FERGUSON
Correspondent
Barco NV Barcoview
12200 Academy Rd. NE, # 931
Albuquerque,  NM  87111
Correspondent Contact FRANK FERGUSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/09/2004
Decision Date 03/29/2004
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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