FDA 510(k)

レクシー・ルメンセルフフィッティング OTC 聴覚補助装置およびレクシーアプリケーション

K番号: K223137 · 2023-03-14

決定日2023-03-14

製品コードQUH

諮問委員会医用工品規制文書の翻訳この医療機器は、FDA（米国食品医薬品局）の510(k)認証を受けた製品です。PMA（プレマーケティング評価）やNCT（臨床試験登録番号）、PMID（PubMed ID）などの識別情報も提供されています。詳細については、以下のURLをご参照ください。 [URL] 政策：medical-regulatory-v1

決定大幅同等

医療機器の概要

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is the device name listed in this FDA 510(k) record. The listed applicant is Hearx SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K223137. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Hearx SA (Pty) , Ltd.. The 510(k) number is K223137.

When did Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application receive FDA 510(k) clearance?

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application received FDA 510(k) clearance on 2023-03-14, under 510(k) number K223137.

Who is the listed applicant for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

The FDA 510(k) record lists Hearx SA (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

The FDA product code for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is QUH.

申請者としてHearx SA (Pty) , Ltd.を記載するその他の記録

K231545hearOAE

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。