FDA 510(k) Application Details - K192048

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K192048
Device Name	Endoscope Channel Accessory
Applicant	Anrei Medical (Hangzhou) Co., Ltd. No. 3 Ave 8, HEDA Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Yang HuiBing Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2019
Decision Date	05/14/2020
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