FDA.reportPublic FDA data

510(k) K222722

Device
CW60N
Applicant
Wide Corporation
510(k) number
K222722
Product code
PGY
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-31
Date received
2022-09-08
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
YeoJin Yun
Address
15f, The First Tower Iii, 602, Dongtangiheung-Ro Hwaseong-Si KR 18469 18469

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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