FDA 510(k)

Insulin Pen Needle

N.º K: K221176 · 2022-07-01

SolicitanteTianjin Huahong Technology Co., Ltd.

Fecha de decisión2022-07-01

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K221176. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Insulin Pen Needle?

Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K221176.

When did Insulin Pen Needle receive FDA 510(k) clearance?

Insulin Pen Needle received FDA 510(k) clearance on 2022-07-01, under 510(k) number K221176.

Who is the listed applicant for Insulin Pen Needle?

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

What is the FDA product code for Insulin Pen Needle?

The FDA product code for Insulin Pen Needle is FMI.

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Dispositivos relacionados (Código: FMI)

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Fuente oficial

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