FDA 510(k)

Belun Ring BLR-100X

Número K: K211407 · 2021-10-21

RequerenteBelun Technology Company Limited

Data da decisão2021-10-21

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Belun Ring BLR-100X is the device name listed in this FDA 510(k) record. The listed applicant is Belun Technology Company Limited. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K211407. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Belun Ring BLR-100X?

Belun Ring BLR-100X is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Belun Technology Company Limited. The 510(k) number is K211407.

When did Belun Ring BLR-100X receive FDA 510(k) clearance?

Belun Ring BLR-100X received FDA 510(k) clearance on 2021-10-21, under 510(k) number K211407.

Who is the listed applicant for Belun Ring BLR-100X?

The FDA 510(k) record lists Belun Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Belun Ring BLR-100X?

The FDA product code for Belun Ring BLR-100X is DQA.

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Fonte oficial

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