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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K200069
Device Name Disposable SpO2 Sensor
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th floor of Xiang dali Technology Park
No.87 of HengPing Road, Henggang
Shenzhen,  CN 518000
Applicant Contact Yahui Zhou
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. A415, Block A, NanShan Medical Devices Industrial Park
Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/13/2020
Decision Date 03/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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