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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 K843920
Device Name FLUOROSCAN/TM BY HEALTHMATE
Original Applicant
HEALTHMATE, INC.
3000 dundee road
northbrook,  IL  60062
Original Contact ken wieselman
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/05/1984
Decision Date 02/07/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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