FDA 510(k)

Disposable Enteral Feeding Syringe with Enfit Connector

Número K: K193657 · 2020-09-12

RequerenteShinva Ande Healthcare Apparatus Co., Ltd.

Data da decisão2020-09-12

Código do produtoPNR

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Enteral Feeding Syringe with Enfit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2020-09-12 under 510(k) number K193657. 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 Disposable Enteral Feeding Syringe with Enfit Connector?

Disposable Enteral Feeding Syringe with Enfit Connector is a medical device that received FDA 510(k) clearance on 2020-09-12. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K193657.

When did Disposable Enteral Feeding Syringe with Enfit Connector receive FDA 510(k) clearance?

Disposable Enteral Feeding Syringe with Enfit Connector received FDA 510(k) clearance on 2020-09-12, under 510(k) number K193657.

Who is the listed applicant for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector is PNR.

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Outros registros que listam Shinva Ande Healthcare Apparatus Co., Ltd. como candidato(a)

K201460Closed System Transfer Device K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles K202060Disposable IV catheter K162601Infusion Set for Single Use

Dispositivos Relacionados (Código: PNR)

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