FDA 510(k) Application Details - K240044

Device Classification Name	More FDA Info for this Device
510(K) Number	K240044
Device Name	CADDIE
Applicant	Odin Medical Limited 43-45 Foley Street London W1W 7TS GB Other 510(k) Applications for this Company
Contact	Luke Sampson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2024
Decision Date	07/24/2024
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