FDA 510(k)

Filter and HME/Filter

N.º K: K221472 · 2023-02-08

SolicitanteNingbo Huakun Medical Equipment Co., Ltd.

Fecha de decisión2023-02-08

Código de productoCAH

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Filter and HME/Filter is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Huakun Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K221472. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Filter and HME/Filter?

Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Ningbo Huakun Medical Equipment Co., Ltd.. The 510(k) number is K221472.

When did Filter and HME/Filter receive FDA 510(k) clearance?

Filter and HME/Filter received FDA 510(k) clearance on 2023-02-08, under 510(k) number K221472.

Who is the listed applicant for Filter and HME/Filter?

The FDA 510(k) record lists Ningbo Huakun Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Filter and HME/Filter?

The FDA product code for Filter and HME/Filter is CAH.

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Fuente oficial

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