FDA 510(k) Application Details - K153620

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K153620
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	OREON TECHNOLOGIES INC. 520 WHITE PLAINS RD HARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	Howard Fidel Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2015
Decision Date	05/05/2016
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