A8, A9 Anesthesia System

Gas-machine, Anesthesia

Shenzhen Mindray Bio-Medical Electronics Co., LTD.

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for A8, A9 Anesthesia System.

Pre-market Notification Details

Device IDK201957
510k NumberK201957
Device Name:A8, A9 Anesthesia System
ClassificationGas-machine, Anesthesia
Applicant Shenzhen Mindray Bio-Medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
ContactYanhong Bai
CorrespondentYanhong Bai
Shenzhen Mindray Bio-Medical Electronics Co., LTD. Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen,  CN 518057
Product CodeBSZ  
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeKDP
Subsequent Product CodeNHO
Subsequent Product CodeNHP
Subsequent Product CodeNHQ
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-14
Decision Date2021-03-26

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.