FDA 510(k)

HeartKey® Rhythm

Número K: K233755 · 2024-08-16

Data da decisão2024-08-16

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

HeartKey® Rhythm is the device name listed in this FDA 510(k) record. The listed applicant is B-Secur Limited. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K233755. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HeartKey® Rhythm?

HeartKey® Rhythm is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is B-Secur Limited. The 510(k) number is K233755.

When did HeartKey® Rhythm receive FDA 510(k) clearance?

HeartKey® Rhythm received FDA 510(k) clearance on 2024-08-16, under 510(k) number K233755.

Who is the listed applicant for HeartKey® Rhythm?

The FDA 510(k) record lists B-Secur Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeartKey® Rhythm?

The FDA product code for HeartKey® Rhythm is DQK.

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Fonte oficial

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