Disposable SpO2 Sensor

Oximeter

Shenzhen Changke Connect Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Spo2 Sensor.

Pre-market Notification Details

Device IDK200069
510k NumberK200069
Device Name:Disposable SpO2 Sensor
ClassificationOximeter
Applicant Shenzhen Changke Connect Electronics Co., Ltd. A2-4th Floor Of Xiang Dali Technology Park No.87 Of HengPing Road, Henggang Shenzhen,  CN 518000
ContactYahui Zhou
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 Received2020-01-13
Decision Date2020-03-13

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