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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, Bldg. #1 E., Huijuang Industrial Area
Xitian Community, Gongming Town, Guangming District
Shenzhen,  CN 518107
Applicant Contact Fu Jian
Correspondent
Shenzhen Upnmed Equipment Co., Ltd.
4th Floor, Bldg. #1 E., 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
Predetermined Change
Control Plan Authorized		 No
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