Reusable And Disposable SpO2 Sensors

Oximeter

Xinkang Medical Instrument Co. Ltd.

The following data is part of a premarket notification filed by Xinkang Medical Instrument Co. Ltd. with the FDA for Reusable And Disposable Spo2 Sensors.

Pre-market Notification Details

Device IDK201360
510k NumberK201360
Device Name:Reusable And Disposable SpO2 Sensors
ClassificationOximeter
Applicant Xinkang Medical Instrument Co. Ltd. 2 Floor, Puhua S&T Park, Tongsheng Community Dalang Street, Longhua District Shenzhen,  CN 518109
ContactXu Changsheng
CorrespondentJames Tsai
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-21
Decision Date2020-08-19

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