Disposable SpO2 Sensor

Oximeter

Shenzhen SINO-K Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Sino-k Medical Technology Co., Ltd. with the FDA for Disposable Spo2 Sensor.

Pre-market Notification Details

Device IDK192608
510k NumberK192608
Device Name:Disposable SpO2 Sensor
ClassificationOximeter
Applicant Shenzhen SINO-K Medical Technology Co., Ltd. Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen,  CN 518000
ContactLao Chengxin
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park, Nanshan District Shenzhen,  CN 518067
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2020-01-24

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