FDA 510(k)

Sterile Single-use Infusion Set

Número K: K163160 · 2017-04-20

RequerenteJiangxi Hongda Medical Equipment Group , Ltd.

Data da decisão2017-04-20

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Single-use Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K163160. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Single-use Infusion Set?

Sterile Single-use Infusion Set is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163160.

When did Sterile Single-use Infusion Set receive FDA 510(k) clearance?

Sterile Single-use Infusion Set received FDA 510(k) clearance on 2017-04-20, under 510(k) number K163160.

Who is the listed applicant for Sterile Single-use Infusion Set?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single-use Infusion Set?

The FDA product code for Sterile Single-use Infusion Set is FPA.

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Outros registros que listam Jiangxi Hongda Medical Equipment Group , Ltd. como candidato(a)

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Dispositivos Relacionados (Código: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development 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)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

Fonte oficial

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