MX50N(MX50YQS)

Display, Diagnostic Radiology

WIDE Corporation

The following data is part of a premarket notification filed by Wide Corporation with the FDA for Mx50n(mx50yqs).

Pre-market Notification Details

Device IDK170781
510k NumberK170781
Device Name:MX50N(MX50YQS)
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 Received2017-03-15
Decision Date2017-04-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809241513087 K170781 000

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