FDA 510(k)

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

K番号: K203133 · 2021-03-24

決定日2021-03-24

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 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.

よくある質問

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.

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

K191387ENvizion 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 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

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