FDA 510(k)

ENvizion メディカル ENVue システム、ENvizion メディカルエンタルフィードィングツイスト

K番号: K191387 · 2019-06-14

決定日2019-06-14

製品コードKNT

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてEnvizion Medical , Ltd.を記載するその他の記録

K203133ENvizion メディカル ENvue ENvizion メディカルエンタルフィードツイスト K182915ENvizion メディカル ENvue；ENvizion メディカルエンタルフィードツイスト

公式ソース

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