FDA 510(k) Application Details - K162094

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K162094
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Samsung Medison Co., Ltd 42, Teheran-ro 108-gil, Gangnam-gu Seoul KR Other 510(k) Applications for this Company
Contact	Kyeong-Mi Park 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	07/28/2016
Decision Date	08/26/2016
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	Y
Expedited Review