FDA 510(k) Application Details - K211665

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K211665
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	HEALCERION CO., LTD. 1403-ho, 12, Digital-ro 33-gil, Guro-gu Seoul 08377 KR Other 510(k) Applications for this Company
Contact	Lee Sooyeol 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	06/01/2021
Decision Date	05/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review