FDA 510(k) Application Details - K211529

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K211529
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	NaviFUS Corporation 12F., No. 246, Sec. 3, Chengde Rd. Datong Dist., Taipei City 10367 TW Other 510(k) Applications for this Company
Contact	Arthur Lung 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	05/17/2021
Decision Date	05/05/2022
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