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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 K212665
Device Name Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
Applicant
Huizhou Xiaoou Technology Co., Ltd.
3rd Floor, No.113 (Building D), Xikeng Industrial Zone
Zhongkai High-tech Zone
Huizhou,  CN 516000
Applicant Contact Xia Wang
Correspondent
Huizhou Xiaoou Technology Co., Ltd.
3rd Floor, No.113 (Building D), Xikeng Industrial Zone
Zhongkai High-tech Zone
Huizhou,  CN 516000
Correspondent Contact Xia Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/23/2021
Decision Date 06/22/2022
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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