FDA 510(k)

ENFit Disposable Enteral Syringe

N.º K: K203410 · 2021-06-28

SolicitanteShantou Wealy Medical Instrument Co.,Ltd

Fecha de decisión2021-06-28

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ENFit Disposable Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2021-06-28 under 510(k) number K203410. 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 Disposable Enteral Syringe?

ENFit Disposable Enteral Syringe is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K203410.

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

ENFit Disposable Enteral Syringe received FDA 510(k) clearance on 2021-06-28, under 510(k) number K203410.

Who is the listed applicant for ENFit Disposable Enteral Syringe?

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

What is the FDA product code for ENFit Disposable Enteral Syringe?

The FDA product code for ENFit Disposable Enteral Syringe is PNR.

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Otros registros que enlistan a Shantou Wealy Medical Instrument Co.,Ltd como solicitante

K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)K210216Disposable Automatically Retractable Insulin Safety Syringe K203613ENFit Reusable Enteral Syringe

Dispositivos relacionados (Código: PNR)

Fuente oficial

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