FDA 510(k) Application Details - K160343

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K160343
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD B2-2 NEW CITY INDUSTRIAL PARK, NO.9 KECHUANG 2ND ST. YIZHUANG BEIJING 100023 CN Other 510(k) Applications for this Company
Contact	JUNE LI 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	02/08/2016
Decision Date	04/07/2016
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