FDA 510(k)

ENFit Oral / Enteral Syringe

Número K: K190502 · 2019-08-06

Data da decisão2019-08-06

Código do produtoPNR

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENFit Oral / Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K190502. 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 ENFit Oral / Enteral Syringe?

ENFit Oral / Enteral Syringe is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K190502.

When did ENFit Oral / Enteral Syringe receive FDA 510(k) clearance?

ENFit Oral / Enteral Syringe received FDA 510(k) clearance on 2019-08-06, under 510(k) number K190502.

Who is the listed applicant for ENFit Oral / Enteral Syringe?

The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFit Oral / Enteral Syringe?

The FDA product code for ENFit Oral / Enteral Syringe is PNR.

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Outros registros que listam Jiangsu Caina Medical Co.,Ltd como candidato(a)

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Fonte oficial

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