FDA 510(k) Application Details - K241897

Device Classification Name	More FDA Info for this Device
510(K) Number	K241897
Device Name	MOR
Applicant	Morari, Inc. 6501 Zircon Lane Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Jeff Bennett Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2024
Decision Date	02/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review