FDA 510(k)

無線Earlens光驅動聽力輔助器

K 號：K153634 · 2016-04-06

決定日期2016-04-06

產品代碼PLK

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

Wireless Earlens Light Driven Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Earlens Corporation. It received FDA 510(k) clearance on 2016-04-06 under 510(k) number K153634. The device is classified under product code PLK. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wireless Earlens Light Driven Hearing Aid?

Wireless Earlens Light Driven Hearing Aid is a medical device that received FDA 510(k) clearance on 2016-04-06. The listed applicant is Earlens Corporation. The 510(k) number is K153634.

When did Wireless Earlens Light Driven Hearing Aid receive FDA 510(k) clearance?

Wireless Earlens Light Driven Hearing Aid received FDA 510(k) clearance on 2016-04-06, under 510(k) number K153634.

Who is the listed applicant for Wireless Earlens Light Driven Hearing Aid?

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

What is the FDA product code for Wireless Earlens Light Driven Hearing Aid?

The FDA product code for Wireless Earlens Light Driven Hearing Aid is PLK.

其他以 Earlens Corporation 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。

K182480艾爾倫斯聯繫式聽力輔助器

相關器械（代碼：PLK）

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。

K182480艾爾倫斯聯繫式聽力輔助器Earlens Corporation

官方來源

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