FDA 510(k)

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

Número K: K191387 · 2019-06-14

Data da decisão2019-06-14

Código do produtoKNT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is the device name listed in this FDA 510(k) record. The listed applicant is Envizion Medical , Ltd.. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K191387. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Envizion Medical , Ltd.. The 510(k) number is K191387.

When did ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube receive FDA 510(k) clearance?

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2019-06-14, under 510(k) number K191387.

Who is the listed applicant for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

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

What is the FDA product code for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

The FDA product code for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is KNT.

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Outros registros que listam Envizion Medical , Ltd. como candidato(a)

K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

Dispositivos Relacionados (Código: KNT)

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