TinniLogic 行動式耳鳴管理裝置
K 號：K163094 · 2017-05-17
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決定日期2017-05-17
產品代碼KLW
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
TinniLogic Mobile Tinnitus Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K163094. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TinniLogic Mobile Tinnitus Management Device?
TinniLogic Mobile Tinnitus Management Device is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. The 510(k) number is K163094.
When did TinniLogic Mobile Tinnitus Management Device receive FDA 510(k) clearance?
TinniLogic Mobile Tinnitus Management Device received FDA 510(k) clearance on 2017-05-17, under 510(k) number K163094.
Who is the listed applicant for TinniLogic Mobile Tinnitus Management Device?
The FDA 510(k) record lists Jiangsu Betterlife Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TinniLogic Mobile Tinnitus Management Device?
The FDA product code for TinniLogic Mobile Tinnitus Management Device is KLW.
相關臨床試驗
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相關器械（代碼：KLW）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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