FDA 510(k) Application Details - DEN230023

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230023
Device Name	Rho
Applicant	16 Bit Inc 76 Parker Ave Ancaster L9G1A7 CA Other 510(k) Applications for this Company
Contact	Dr. Catriona Syme Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2023
Decision Date	04/09/2024
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