GMR40

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

NeuroLogica Corporation, A Subsidiary Of

The following data is part of a premarket notification filed by Neurologica Corporation, A Subsidiary Of with the FDA for Gmr40.

Pre-market Notification Details

Device IDK171085
510k NumberK171085
Device Name:GMR40
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant NeuroLogica Corporation, A Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers,  MA  01923
ContactNinad Gujar
CorrespondentNinad Gujar
NeuroLogica Corporation, A Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers,  MA  01923
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-12
Decision Date2017-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10815411020298 K171085 000

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