FDA.report

510(k) K212665

Device
Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
Applicant
Huizhou Xiaoou Technology Co., Ltd.
510(k) number
K212665
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-22
Date received
2021-08-23
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Xia Wang
Address
3rd Floor, #113 (Bldg. D), Xikeng Industrial Zone Zhongkai High-Tech Zone Huizhou CN 516000 516000

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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