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FDA 510(k)

Desyncra 靈敏度調節系統，Desyncra 靈敏度調節專業系統

K 號：K151558 · 2016-01-20

申請人Neurotherapies Reset GmbH
決定日期2016-01-20
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

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is the device name listed in this FDA 510(k) record. The listed applicant is Neurotherapies Reset GmbH. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K151558. 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 Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Neurotherapies Reset GmbH. The 510(k) number is K151558.

When did Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System receive FDA 510(k) clearance?

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System received FDA 510(k) clearance on 2016-01-20, under 510(k) number K151558.

Who is the listed applicant for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

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

What is the FDA product code for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System?

The FDA product code for Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System is KLW.

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