FDA 510(k) Application Details - K153424

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K153424
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	ALPINION MEDICAL SYSTEMS CO., LTD. 1FL and 6FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu SEOUL 08393 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	11/25/2015
Decision Date	02/26/2016
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	N
Expedited Review