FDA 510(k) Application Details - K162972

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K162972
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Exact Imaging 7676 Woodbine Avenue Unit 15 Markham L3R 2N2 CA Other 510(k) Applications for this Company
Contact	Karina Torres 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	10/25/2016
Decision Date	12/02/2016
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	Y
Expedited Review