FDA 510(k) Application Details - DEN220017

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220017
Device Name	BioXmark
Applicant	Nanovi A/S Diplomvej 378 Kgs. Lyngby 2800 DK Other 510(k) Applications for this Company
Contact	Hsiao-Qing Chow Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2022
Decision Date	12/23/2022
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review