Pulse Oximeter

Oximeter

Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Hexin Zondan Medical Equipment Co., Ltd. with the FDA for Pulse Oximeter.

Pre-market Notification Details

Device IDK203854
510k NumberK203854
Device Name:Pulse Oximeter
ClassificationOximeter
Applicant Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. Floor 14, Block D, Dianlian Technology Building, the Crossing Between South Circle Road And South Fuli Road, Shenzhen,  CN 518106
ContactJohn Liu
CorrespondentJohn Liu
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. Floor 14, Block D, Dianlian Technology Building, the Crossing Between South Circle Road And South Fuli Road, Shenzhen,  CN 518106
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-31
Decision Date2021-04-23

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