FDA 510(k) Application Details - DEN220040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220040
Device Name	Fibresolve
Applicant	Imvaria, Inc 1748 Shattuck Ave. PMB 137 Berkley, CA 94709 US Other 510(k) Applications for this Company
Contact	Joshua Reicher Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2022
Decision Date	01/12/2024
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