GX-C CEPHALOMETER

Cephalometer

GENDEX CORP.

The following data is part of a premarket notification filed by Gendex Corp. with the FDA for Gx-c Cephalometer.

Pre-market Notification Details

Device IDK920189
510k NumberK920189
Device Name:GX-C CEPHALOMETER
ClassificationCephalometer
Applicant GENDEX CORP. 901 WEST OAKTON ST. Des Plaines,  IL  60018
ContactGerald Llevy
CorrespondentGerald Llevy
GENDEX CORP. 901 WEST OAKTON ST. Des Plaines,  IL  60018
Product CodeEAG  
CFR Regulation Number872.1830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-15
Decision Date1992-04-28

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