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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 K192608
Device Name Disposable SpO2 Sensor
Applicant
Shenzhen Sino-K Medical Technology Co.,Ltd
Rm.401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang
St.,
Baoan District, Shenzhen,  CN 518000
Applicant Contact Lao Chengxin
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
# 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 Received09/20/2019
Decision Date 01/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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