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 IDK142552
510k NumberK142552
Device Name:A7 Anesthesia System
ClassificationGas-machine, Anesthesia
Applicant ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen,  CN 518057
ContactTang Hao
CorrespondentTang Hao
ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen,  CN 518057
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-10
Decision Date2015-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944904039695 K142552 000

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