FDA 510(k) Application Details - K240164

Device Classification Name	Protector, Transducer, Dialysis   More FDA Info for this Device
510(K) Number	K240164
Device Name	Protector, Transducer, Dialysis
Applicant	Bain Medical Equipment (Guangzhou) Co., Ltd. No.10 Juncheng Road, No.10, Juncheng Road Eastern Area Economic and Technological Development Guangzhou 510760 CN Other 510(k) Applications for this Company
Contact	Zoe Zeng Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2024
Decision Date	06/28/2024
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