FDA 510(k)

All-Day Clear Slim ADCS1 聽力辅助器。All-Day Clear ADC1 聽力辅助器

K 號：K230538 · 2023-06-16

決定日期2023-06-16

產品代碼QUH

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Sonova AG. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230538. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid?

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Sonova AG. The 510(k) number is K230538.

When did All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid receive FDA 510(k) clearance?

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230538.

Who is the listed applicant for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid?

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

What is the FDA product code for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid?

The FDA product code for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid is QUH.

其他以 Sonova AG 為申請人之記錄

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K232999Lyric4 聽力輔助器

相關器械（代碼：QUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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