FDA 510(k)

ENFit Oral / Enteral Syringe

N.º K: K190502 · 2019-08-06

SolicitanteJiangsu Caina Medical Co.,Ltd

Fecha de decisión2019-08-06

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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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.