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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 K001747
Device Name MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
Applicant
BARCO NV DISPLAY SYSTEMS
8524 VILA LA JOLLA DR.
SUITE 161
LA JOLLA,  CA  92037
Applicant Contact FRANK FERGUSON
Correspondent
BARCO NV DISPLAY SYSTEMS
8524 VILA LA JOLLA DR.
SUITE 161
LA JOLLA,  CA  92037
Correspondent Contact FRANK FERGUSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/08/2000
Decision Date 07/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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