FDA 510(k)

WSA 自調整型ヘリングエイドゲン2

K番号: K233464 · 2024-02-09

決定日2024-02-09

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

WSA Self-Fitting Hearing Aid Gen 2 is the device name listed in this FDA 510(k) record. The listed applicant is Wsaud A/S. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K233464. 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 WSA Self-Fitting Hearing Aid Gen 2?

WSA Self-Fitting Hearing Aid Gen 2 is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Wsaud A/S. The 510(k) number is K233464.

When did WSA Self-Fitting Hearing Aid Gen 2 receive FDA 510(k) clearance?

WSA Self-Fitting Hearing Aid Gen 2 received FDA 510(k) clearance on 2024-02-09, under 510(k) number K233464.

Who is the listed applicant for WSA Self-Fitting Hearing Aid Gen 2?

The FDA 510(k) record lists Wsaud A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WSA Self-Fitting Hearing Aid Gen 2?

The FDA product code for WSA Self-Fitting Hearing Aid Gen 2 is QUH.

申請者としてWsaud A/Sを記載するその他の記録

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