FDA 510(k)

SION blue PLUS

N.º K: K243733 · 2025-04-02

Fecha de decisión2025-04-02

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Otros registros que enlistan a Asahi Intecc Co., Ltd. como solicitante

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.