Belun Ring BLR-100X— 510(k) K211407

Substantially Equivalent

Belun Technology Company Limited

FDA 510(k) clearance K211407 for Belun Ring BLR-100X, Substantially Equivalent on 2021-10-21. Applicant: Belun Technology Company Limited.

Clearance details

Applicant: Belun Technology Company Limited
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2021-05-06
Decision date: 2021-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sha Tin, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.