FDA 510(k)

SION blue PLUS

Número K: K243733 · 2025-04-02

Data da decisão2025-04-02

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SION blue PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K243733. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SION blue PLUS?

SION blue PLUS is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K243733.

When did SION blue PLUS receive FDA 510(k) clearance?

SION blue PLUS received FDA 510(k) clearance on 2025-04-02, under 510(k) number K243733.

Who is the listed applicant for SION blue PLUS?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SION blue PLUS?

The FDA product code for SION blue PLUS is DQX.

Outros registros que listam Asahi Intecc Co., Ltd. como candidato(a)

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Fonte oficial

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