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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 K201360
Device Name Reusable and Disposable SpO2 Sensors
Applicant
Xinkang Medical Instrument Co. Ltd.
2 Floor, Puhua S&T Park, Tongsheng Community Dalang Street,
Longhua District
Shenzhen,  CN 518109
Applicant Contact Xu Changsheng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact James Tsai
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/21/2020
Decision Date 08/19/2020
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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