FDA 510(k) Application Details - K231822

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K231822
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	Batrik Medical Manufacturing Inc. 2165 46th Ave Lachine H8T 2P1 CA Other 510(k) Applications for this Company
Contact	Suzy Bairos Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2023
Decision Date	02/26/2024
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