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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 K191279
Device Name Disposable SpO2 Sensor
Shenzhen Caremed Medical Technology Co., Ltd.
East Side, 3/F, C Building, Kelunte Low-Carbon Industries
Gaofeng Community
Dalang Office, Longhua District, Shenzhe,  CN 518109
Applicant Contact Alan Xie
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
Date Received05/13/2019
Decision Date 12/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No