Solid State X-ray Imager (flat Panel/digital Imager)

Bontech Co. Ltd

The following data is part of a premarket notification filed by Bontech Co. Ltd with the FDA for Bsd3543w.

Pre-market Notification Details

Device IDK200787
510k NumberK200787
Device Name:BSD3543W
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Bontech Co. Ltd Digital Empire D-Bldg #1201, Deogyeong-daero 1556 Beon-gil, Yeongtong-gu Suwon-si,  KR 443-702
ContactKi Chan Ahn
CorrespondentDave Kim
Mtech Group 7707 Fannin St Ste 200 Houston,  TX  77054
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-04-23

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