A7 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 A7 Anesthesia System.

Pre-market Notification Details

Device IDK171292
510k NumberK171292
Device Name:A7 Anesthesia System
ClassificationGas-machine, Anesthesia
Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South , Hi-tech Industrial Park, Shenzhen,  CN 518057
ContactYanhong Bai
CorrespondentYanhong Bai
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South , Hi-tech Industrial Park, Shenzhen,  CN 518057
Product CodeBSZ  
Subsequent Product CodeCBQ
Subsequent Product CodeCBR
Subsequent Product CodeCBS
Subsequent Product CodeCCK
Subsequent Product CodeCCL
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 Received2017-05-02
Decision Date2018-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904000244 K171292 000
06944904000237 K171292 000

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