FDA.report

510(k) K211407

Device
Belun Ring BLR-100X
Applicant
Belun Technology Company Limited
510(k) number
K211407
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-21
Date received
2021-05-06
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
Unit 218, 2/F, Core Bldg. 2, # 1 Science Park West Ave., Hong Kong Science Park Sha Tin CN

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
04897140630114Belun RingBelun Technology Company Limited2025-11-13
04899959015007Belun RingBelun Technology Company Limited2023-12-05
04899959015090Belun RingBelun Technology Company Limited2022-04-13
04899959015083Belun RingBelun Technology Company Limited2022-04-13
04899959015076Belun RingBelun Technology Company Limited2022-04-13

Legacy Summary

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FDA Review

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