FDA 510(k)

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

N.º K: K202319 · 2021-11-12

SolicitanteTianjin Huahong Technology Co., Ltd.

Fecha de decisión2021-11-12

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) 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 2021-11-12 under 510(k) number K202319. 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 (Ordinary Type), Insulin Pen Needle (Safety Type)?

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K202319.

When did Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) receive FDA 510(k) clearance?

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) received FDA 510(k) clearance on 2021-11-12, under 510(k) number K202319.

Who is the listed applicant for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?

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 (Ordinary Type), Insulin Pen Needle (Safety Type)?

The FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is FMI.

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Dispositivos relacionados (Código: FMI)

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Fuente oficial

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