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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K935046
Device Name GX-770 X-RAY CONTROL, MODEL 46-404600G4
Applicant
Gendex Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent
Gendex Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Regulation Number872.1800
Classification Product Code
EHD  
Date Received10/20/1993
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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