FDA 510(k) Application Details - K153037

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K153037
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC 9900 W. INNOVATION DRIVE WAUWATOSA, WI 53226 US Other 510(k) Applications for this Company
Contact	Tracey Ortiz 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	10/19/2015
Decision Date	01/04/2016
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