FDA 510(k) Application Details - K223564

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K223564
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	Alpinion Medical Systems Co., Ltd. 4F, 15, Magokjunang 14-ro, Gangseo-gu Seoul 07789 KR Other 510(k) Applications for this Company
Contact	Boyeon CHO 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	11/29/2022
Decision Date	04/17/2023
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