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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K943272
Device Name VISUALIZER 2000
Applicant
Vf-Works, Inc.
973 Virginia Ave. Suite 11
Palm Harbor,  FL  34683
Applicant Contact JOHN R POSTLETHWAITE
Correspondent
Vf-Works, Inc.
973 Virginia Ave. Suite 11
Palm Harbor,  FL  34683
Correspondent Contact JOHN R POSTLETHWAITE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/07/1994
Decision Date 12/27/1994
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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