FDA 510(k) Application Details - K130119

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K130119
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	SONOSCAPE COMPANY LIMITED Nanfeng Building, Nanshan Yungu Innovation Industrial Park No. 1183 Liuxian Avenue, Taoyuan Street, Nanshan District SHENZHEN 518055 CN Other 510(k) Applications for this Company
Contact	TOKI WU 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	01/16/2013
Decision Date	04/12/2013
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