FDA 510(k)

B-Secur HeartKey Software Library

Número K: K200884 · 2020-12-07

Data da decisão2020-12-07

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

B-Secur HeartKey Software Library is the device name listed in this FDA 510(k) record. The listed applicant is B-Secur , Ltd.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K200884. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the B-Secur HeartKey Software Library?

B-Secur HeartKey Software Library is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is B-Secur , Ltd.. The 510(k) number is K200884.

When did B-Secur HeartKey Software Library receive FDA 510(k) clearance?

B-Secur HeartKey Software Library received FDA 510(k) clearance on 2020-12-07, under 510(k) number K200884.

Who is the listed applicant for B-Secur HeartKey Software Library?

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

What is the FDA product code for B-Secur HeartKey Software Library?

The FDA product code for B-Secur HeartKey Software Library is DPS.

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