FDA 510(k) Application Details - K142884

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K142884
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU SEOUL 152-848 KR Other 510(k) Applications for this Company
Contact	Donghwan 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	10/02/2014
Decision Date	10/28/2014
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