FDA 510(k) Application Details - K241532

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K241532
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	Shanghai SeeGen Photoelectric Technology Co., Ltd. 3 Floor, Building No.1, 4299 JinDu Road, Minhang District Shanghai 201108 CN Other 510(k) Applications for this Company
Contact	Yihua Ma Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2024
Decision Date	10/22/2024
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