CX30N (CX30PQX)

Display, Diagnostic Radiology

Wide Corporation

The following data is part of a premarket notification filed by Wide Corporation with the FDA for Cx30n (cx30pqx).

Pre-market Notification Details

Device IDK210493
510k NumberK210493
Device Name:CX30N (CX30PQX)
ClassificationDisplay, Diagnostic Radiology
Applicant Wide Corporation 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-si,  KR 18469
ContactYeojin Yun
CorrespondentYeojin Yun
Wide Corporation 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-si,  KR 18469
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-19
Decision Date2021-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809241513131 K210493 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.