GX-MOBILE X-RAY UNIT

System, X-ray, Mobile

GENDEX CORP.

The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-mobile X-ray Unit.

Pre-market Notification Details

Device IDK873982
510k NumberK873982
Device Name:GX-MOBILE X-RAY UNIT
ClassificationSystem, X-ray, Mobile
Applicant GENDEX CORP. 11341 W. MELROSE ST. Franklin Park,  IL  60131
ContactGerald V Levy
CorrespondentGerald V Levy
GENDEX CORP. 11341 W. MELROSE ST. Franklin Park,  IL  60131
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-30
Decision Date1987-10-30

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