FDA 510(k) Application Details - K250010

Device Classification Name	More FDA Info for this Device
510(K) Number	K250010
Device Name	EXTRON 3; 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	Minjeong Kim 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	01/02/2025
Decision Date	06/10/2025
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