FDA 510(k) Application Details - K153408

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K153408
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL GANGNAM-GU SEOUL 135-851 KR Other 510(k) Applications for this Company
Contact	Jiyoung Kim 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	11/25/2015
Decision Date	12/21/2015
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	Y
Expedited Review