FDA 510(k) Application Details - K222717

Device Classification Name

  More FDA Info for this Device
510(K) Number K222717
Device Name CL24N
Applicant WIDE Corporation
15F, The First Tower III, 602, Dongtangiheung-Ro
Hwaseong-Si 18469 CN
Other 510(k) Applications for this Company
Contact YeoJin Yun
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code PGY
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/08/2022
Decision Date 10/31/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact