FDA 510(k)

Jeringa de Alimentación Enteral AMSure® con Conector ENFit

N.º K: K171857 · 2018-03-30

Fecha de decisión2018-03-30

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AMSure® Enteral Feeding Syringe with ENFit Tip is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K171857. 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 AMSure® Enteral Feeding Syringe with ENFit Tip?

AMSure® Enteral Feeding Syringe with ENFit Tip is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Amsino International, Inc.. The 510(k) number is K171857.

When did AMSure® Enteral Feeding Syringe with ENFit Tip receive FDA 510(k) clearance?

AMSure® Enteral Feeding Syringe with ENFit Tip received FDA 510(k) clearance on 2018-03-30, under 510(k) number K171857.

Who is the listed applicant for AMSure® Enteral Feeding Syringe with ENFit Tip?

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

What is the FDA product code for AMSure® Enteral Feeding Syringe with ENFit Tip?

The FDA product code for AMSure® Enteral Feeding Syringe with ENFit Tip is PNR.

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Otros registros que enlistan a Amsino International, Inc. como solicitante

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding Pump K220267AMSafe NeuFlo Needleless Connector K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe

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Dispositivos relacionados (Código: PNR)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.