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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 K022773
Device Name BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
Applicant
BARCO NV
P.O. BOX 12038
LA JOLLA,  CA  92039 -2038
Applicant Contact FRANK FERGUSON
Correspondent
BARCO NV
P.O. BOX 12038
LA JOLLA,  CA  92039 -2038
Correspondent Contact FRANK FERGUSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/21/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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