FDA 510(k) Application Details - K223473

Device Classification Name	More FDA Info for this Device
510(K) Number	K223473
Device Name	ME-APDSÖ; MAGENTIQ-COLOÖ
Applicant	Magentiq Eye LTD 6 Ben Gurion Blvd. Haifa 3541416 IL Other 510(k) Applications for this Company
Contact	Dror Zur 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	11/17/2022
Decision Date	07/25/2023
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