FDA 510(k) Application Details - K230497

Device Classification Name	More FDA Info for this Device
510(K) Number	K230497
Device Name	Bladder AI (AIBV01)
Applicant	Exo Inc 4201 Burton Drive Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Jacqueline Murray Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2023
Decision Date	06/22/2023
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