FDA 510(k)

Monoject Enteral Syringe with ENFit Connector

Número K: K161963 · 2016-09-01

Data da decisão2016-09-01

Código do produtoPNR

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Monoject Enteral Syringe with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K161963. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Monoject Enteral Syringe with ENFit Connector?

Monoject Enteral Syringe with ENFit Connector is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Covidien. The 510(k) number is K161963.

When did Monoject Enteral Syringe with ENFit Connector receive FDA 510(k) clearance?

Monoject Enteral Syringe with ENFit Connector received FDA 510(k) clearance on 2016-09-01, under 510(k) number K161963.

Who is the listed applicant for Monoject Enteral Syringe with ENFit Connector?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monoject Enteral Syringe with ENFit Connector?

The FDA product code for Monoject Enteral Syringe with ENFit Connector is PNR.

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Fonte oficial

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