FDA 510(k) Application Details - K122583

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K122583
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
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	08/24/2012
Decision Date	09/05/2012
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