FDA 510(k)

EARP神經袖電極

K 號：K241917 · 2024-07-31

決定日期2024-07-31

產品代碼ETN

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

EARP Nerve Cuff Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Retropsoas Technologies, LLC. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K241917. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EARP Nerve Cuff Electrode?

EARP Nerve Cuff Electrode is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Retropsoas Technologies, LLC. The 510(k) number is K241917.

When did EARP Nerve Cuff Electrode receive FDA 510(k) clearance?

EARP Nerve Cuff Electrode received FDA 510(k) clearance on 2024-07-31, under 510(k) number K241917.

Who is the listed applicant for EARP Nerve Cuff Electrode?

The FDA 510(k) record lists Retropsoas Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARP Nerve Cuff Electrode?

The FDA product code for EARP Nerve Cuff Electrode is ETN.

其他以 Retropsoas Technologies, LLC 為申請人之記錄

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K242457EARP 間體系統

相關器械（代碼：ETN）

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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