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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K890083
Device Name GX-2000 STATIONARY X-RAY GENERATOR
Applicant
Gendex Corp.
11341 W. Melrose St.
Franklin Park,  IL  60131
Applicant Contact GERALD V LEVY
Correspondent
Gendex Corp.
11341 W. Melrose St.
Franklin Park,  IL  60131
Correspondent Contact GERALD V LEVY
Regulation Number892.1700
Classification Product Code
IZO  
Date Received01/10/1989
Decision Date 03/31/1989
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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