FDA 510(k) Application Details - K223754

Device Classification Name	More FDA Info for this Device
510(K) Number	K223754
Device Name	BraveCX
Applicant	Bering Ltd 54 Portland Place, 2nd Floor London W1B 1DY GB Other 510(k) Applications for this Company
Contact	Drozdov Ignat Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2022
Decision Date	11/09/2023
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