FDA 510(k) Application Details - K151175

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K151175
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	ZONARE MEDICAL SYSTEMS, INC. 420 NORTH BERNARDO AVENUE MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	STEVE GEERDES 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	05/01/2015
Decision Date	05/15/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review