FDA 510(k) Application Details - K230871

Device Classification Name

  More FDA Info for this Device
510(K) Number K230871
Device Name EXTRON 5; EXTRON 7
Applicant DRTECH Corporation
Suite No. 1, 2 Floor/Suite No. 2, 3 Floor, 29,
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-si 13216 KR
Other 510(k) Applications for this Company
Contact Kim Minjeong
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 03/30/2023
Decision Date 08/17/2023
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