ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
K-Number: K191387 · 2019-06-14
ApplicantEnvizion Medical , Ltd.
Decision Date2019-06-14
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is a medical device manufactured by Envizion Medical , Ltd.. It received FDA 510(k) clearance on 2019-06-14 under approval number K191387. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Envizion Medical , Ltd.. The 510(k) number is K191387.
When was ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube approved by the FDA?
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2019-06-14, under approval number K191387.
What company makes ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is manufactured by Envizion Medical , Ltd..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.