FDA 510(k) Application Details - K240296

Device Classification Name	More FDA Info for this Device
510(K) Number	K240296
Device Name	Tulsa Pro System (Pad-105)
Applicant	Profound Medical, Inc. 2400 Skymark Ave #6 Mississauga L4W 5K5 CA Other 510(k) Applications for this Company
Contact	Golddy Kaur Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2024
Decision Date	05/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review