SDX-4343CS

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

SAMSUNG MOBILE DISPLAY CO., LTD

The following data is part of a premarket notification filed by Samsung Mobile Display Co., Ltd with the FDA for Sdx-4343cs.

Pre-market Notification Details

Device IDK112751
510k NumberK112751
Device Name:SDX-4343CS
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant SAMSUNG MOBILE DISPLAY CO., LTD 12946 KIMBERLEY LANE Houston,  TX  77079
ContactDave Kim
CorrespondentDave Kim
SAMSUNG MOBILE DISPLAY CO., LTD 12946 KIMBERLEY LANE Houston,  TX  77079
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-21
Decision Date2011-11-23
Summary:summary

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