FDA 510(k)

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)

N.º K: K162188 · 2016-09-22

Fecha de decisión2016-09-22

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is the device name listed in this FDA 510(k) record. The listed applicant is Vr Medical Technology. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K162188. 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 Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Vr Medical Technology. The 510(k) number is K162188.

When did Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) receive FDA 510(k) clearance?

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) received FDA 510(k) clearance on 2016-09-22, under 510(k) number K162188.

Who is the listed applicant for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

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

What is the FDA product code for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)?

The FDA product code for Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) is PNR.

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Dispositivos relacionados (Código: PNR)

Fuente oficial

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