FDA 510(k)

Jabra Enhance Select 自選配 (Jabra Enhance Select 550)

K 號：K254108 · 2026-06-25

決定日期2026-06-25

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

Jabra Enhance Select Self-fit (Jabra Enhance Select 550) is the device name listed in this FDA 510(k) record. The listed applicant is GN Hearing A/S. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K254108. 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 Jabra Enhance Select Self-fit (Jabra Enhance Select 550)?

Jabra Enhance Select Self-fit (Jabra Enhance Select 550) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is GN Hearing A/S. The 510(k) number is K254108.

When did Jabra Enhance Select Self-fit (Jabra Enhance Select 550) receive FDA 510(k) clearance?

Jabra Enhance Select Self-fit (Jabra Enhance Select 550) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K254108.

Who is the listed applicant for Jabra Enhance Select Self-fit (Jabra Enhance Select 550)?

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

What is the FDA product code for Jabra Enhance Select Self-fit (Jabra Enhance Select 550)?

The FDA product code for Jabra Enhance Select Self-fit (Jabra Enhance Select 550) is QUH.

其他以 GN Hearing A/S 為申請人之記錄

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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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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