FDA 510(k)

Intrisound™ 調節光輻® 155 聽力輔助器

K 號：K223848 · 2023-09-08

決定日期2023-09-08

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

Intrisound™ Tuned Lumen® 155 Hearing Aids is the device name listed in this FDA 510(k) record. The listed applicant is Tuned , Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K223848. 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 Intrisound™ Tuned Lumen® 155 Hearing Aids?

Intrisound™ Tuned Lumen® 155 Hearing Aids is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Tuned , Ltd.. The 510(k) number is K223848.

When did Intrisound™ Tuned Lumen® 155 Hearing Aids receive FDA 510(k) clearance?

Intrisound™ Tuned Lumen® 155 Hearing Aids received FDA 510(k) clearance on 2023-09-08, under 510(k) number K223848.

Who is the listed applicant for Intrisound™ Tuned Lumen® 155 Hearing Aids?

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

What is the FDA product code for Intrisound™ Tuned Lumen® 155 Hearing Aids?

The FDA product code for Intrisound™ Tuned Lumen® 155 Hearing Aids is QUH.

其他以 Tuned , Ltd. 為申請人之記錄

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K251208調頻自適應移動應用程式

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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