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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 K843917
Device Name FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL
Applicant
Afp Imaging Corp.
9410 M Desoto Ave.
Chatsworth,  CA  91311
Applicant Contact ROBERT E JOHNSON
Correspondent
Afp Imaging Corp.
9410 M Desoto Ave.
Chatsworth,  CA  91311
Correspondent Contact ROBERT E JOHNSON
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/05/1984
Decision Date 01/03/1985
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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