FDA.report

510(k) K210305

Device
Pulse Oximeter
Applicant
Dongguan Lingxin Technologies Co., LTD
510(k) number
K210305
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-22
Date received
2021-02-03
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
Cony Tang
Address
Rm. 301, # 3 Liantang Rd., Aoshitang, Dongcheng St. Dongguan CN 523129 523129

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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