FDA 510(k)

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube

Número K: K203133 · 2021-03-24

Data da decisão2021-03-24

Código do produtoKNT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENvizion Medical ENvue 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 2021-03-24 under 510(k) number K203133. 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 ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Envizion Medical , Ltd.. The 510(k) number is K203133.

When did ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube receive FDA 510(k) clearance?

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203133.

Who is the listed applicant for ENvizion Medical ENvue 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 ENvizion Medical Enteral Feeding Tube?

The FDA product code for ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube is KNT.

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

K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

Dispositivos Relacionados (Código: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

Fonte oficial

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