MX30N(MX30TQS)

Display, Diagnostic Radiology

WIDE Corporation

The following data is part of a premarket notification filed by Wide Corporation with the FDA for Mx30n(mx30tqs).

Pre-market Notification Details

Device IDK160346
510k NumberK160346
Device Name:MX30N(MX30TQS)
ClassificationDisplay, Diagnostic Radiology
Applicant WIDE Corporation 12 Wongomae-Ro, Giheung-Gu Yongin-si,  KR 17086
ContactYeojin Yun
CorrespondentYeojin Yun
WIDE Corporation 12 Wongomae-Ro, Giheung-Gu Yongin-si,  KR 17086
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-08
Decision Date2016-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809241513025 K160346 000

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