FDA 510(k) Application Details - K173486

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K173486
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	National Taiwan University No. 1, Sec. 4, Roosevelt Rd., Taipei 10617, Taiwan (R.O.C) Taipei 10617 TW Other 510(k) Applications for this Company
Contact	Pai-Chi Li 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	11/13/2017
Decision Date	07/11/2018
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