FDA 510(k)

Applied Medical アノスコープ

K番号: K200021 · 2021-01-06

決定日2021-01-06

製品コードFER

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

Applied Medical Anoscope is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K200021. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Applied Medical Anoscope?

Applied Medical Anoscope is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Applied Medical Resources. The 510(k) number is K200021.

When did Applied Medical Anoscope receive FDA 510(k) clearance?

Applied Medical Anoscope received FDA 510(k) clearance on 2021-01-06, under 510(k) number K200021.

Who is the listed applicant for Applied Medical Anoscope?

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

What is the FDA product code for Applied Medical Anoscope?

The FDA product code for Applied Medical Anoscope is FER.

申請者としてApplied Medical Resourcesを記載するその他の記録

K162676Voyant Open Fusion Device K153017Voyant Fine Fusion K153288Voyant Open Fusion Device K151480エピックス電気外科プローブおよび煙吸引装置

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。