GX CEPH

Cephalometer

GENDEX CORP.

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

Pre-market Notification Details

Device IDK842463
510k NumberK842463
Device Name:GX CEPH
ClassificationCephalometer
Applicant GENDEX CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEAG  
CFR Regulation Number872.1830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-22
Decision Date1984-08-02

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