FDA 510(k) Application Details - K231677

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K231677
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Edgecare Inc. 403, Teihard Hall, 35, Baekbeom-ro, Mapo-gu Seoul 04107 KR Other 510(k) Applications for this Company
Contact	Park Sangeun Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2023
Decision Date	03/06/2024
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