FDA 510(k)

AMSure® Enteral Feeding Syringe with ENFit Tip

Número K: K171857 · 2018-03-30

Data da decisão2018-03-30

Código do produtoPNR

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Amsino International, Inc. como candidato(a)

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)

Fonte oficial

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