FDA 510(k) Application Details - K201957

Device Classification Name	Gas-Machine, Anesthesia   More FDA Info for this Device
510(K) Number	K201957
Device Name	Gas-Machine, Anesthesia
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen 518057 CN Other 510(k) Applications for this Company
Contact	Yanhong Bai Other 510(k) Applications for this Contact
Regulation Number	868.5160   More FDA Info for this Regulation Number
Classification Product Code	BSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2020
Decision Date	03/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review