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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 K183277
Device Name SpO2 Sensor
Applicant
Shenzhen Upnmed Equipment Co., Ltd.
4th Floor, Building #1 East, Huijuang Industrial Area
Xitian Community, Gongming Town, Guangming District
Shenzhen,  CN 518107
Applicant Contact Fu Jian
Correspondent
Shenzhen Upnmed Equipment Co., Ltd.
4th Floor, Building #1 East, Huihuang Industrial Area
Xitian Community, Gongming Town, Guangming District
Shenzhen,  CN 518107
Correspondent Contact Fu Jian
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/23/2018
Decision Date 05/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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