FDA 510(k) Application Details - K191235

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K191235
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Leltek Inc 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City 23147 TW Other 510(k) Applications for this Company
Contact	Kiefe Chang Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2019
Decision Date	02/12/2020
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