FDA 510(k)

Oral/Enteral Syringe with ENFit connector

N.º K: K211025 · 2021-06-30

SolicitanteNingbo Tianyi Medical Appliance Co., Ltd.

Fecha de decisión2021-06-30

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Oral/Enteral Syringe with ENFit connector is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K211025. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Oral/Enteral Syringe with ENFit connector?

Oral/Enteral Syringe with ENFit connector is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. The 510(k) number is K211025.

When did Oral/Enteral Syringe with ENFit connector receive FDA 510(k) clearance?

Oral/Enteral Syringe with ENFit connector received FDA 510(k) clearance on 2021-06-30, under 510(k) number K211025.

Who is the listed applicant for Oral/Enteral Syringe with ENFit connector?

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

What is the FDA product code for Oral/Enteral Syringe with ENFit connector?

The FDA product code for Oral/Enteral Syringe with ENFit connector is PNR.

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Fuente oficial

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