FDA 510(k) Application Details - K173265

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K173265
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	WinProbe Corporation 11770 US Highway 1 suite 302E Palm Beach Gardens, FL 33408 US Other 510(k) Applications for this Company
Contact	Guy Scott 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	10/11/2017
Decision Date	11/07/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review