FDA 510(k) Application Details - K150861

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K150861
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	CHISON MEDICAL IMAGING CO., LTD. NO.228, CHANGJIANG EAST ROAD,BLOCK 51 AND 53 PHASE 5 INDUSTRIAL PARK, SHUOFA WUXI 214142 CN Other 510(k) Applications for this Company
Contact	QIFEI LIU 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	04/01/2015
Decision Date	07/28/2015
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