System, X-ray, Stationary

DRGEM Corporation

The following data is part of a premarket notification filed by Drgem Corporation with the FDA for Diamond-5a/6a/8a.

Pre-market Notification Details

Device IDK202156
510k NumberK202156
Device Name:DIAMOND-5A/6A/8A
ClassificationSystem, X-ray, Stationary
Applicant DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro Gwangmyeong-si,  KR 14322
ContactKi-nam Yang
CorrespondentCarl Alletto
OTech Lnc. 8317 Belew Drive Mckinney,  TX  75071
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-27
Decision Date2020-09-10

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