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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 K000294
Device Name MFCD 120
Applicant
Barco N.V.
P.O. Box 12038
La Jolla,  CA  92039 -2038
Applicant Contact FRANK FERGUSON
Correspondent
Barco N.V.
P.O. Box 12038
La Jolla,  CA  92039 -2038
Correspondent Contact FRANK FERGUSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/31/2000
Decision Date 03/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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