FDA.report

510(k) K180174

Device
Belun Ring
Applicant
Belun Technology Company Limited
510(k) number
K180174
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2018-05-29
Date received
2018-01-22
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
Leung Lap Wai Lydia
Address
Rm531b, Floor 5, Core Bldg. 2, 1 Science Park W. Ave. Hk Science Park Sha Tin HK

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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