FDA 510(k)

聲選項頭暈治療

K 號：K161562 · 2016-09-28

申請人Sound Options Tinnitus Treatments, Inc.

決定日期2016-09-28

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

Sound Options Tinnitus Treatment is the device name listed in this FDA 510(k) record. The listed applicant is Sound Options Tinnitus Treatments, Inc.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161562. 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 Sound Options Tinnitus Treatment?

Sound Options Tinnitus Treatment is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Sound Options Tinnitus Treatments, Inc.. The 510(k) number is K161562.

When did Sound Options Tinnitus Treatment receive FDA 510(k) clearance?

Sound Options Tinnitus Treatment received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161562.

Who is the listed applicant for Sound Options Tinnitus Treatment?

The FDA 510(k) record lists Sound Options Tinnitus Treatments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sound Options Tinnitus Treatment?

The FDA product code for Sound Options Tinnitus Treatment is KLW.

相關器械（代碼：KLW）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KLW）

官方來源