FDA 510(k)

一次性喉電極

K 號：K232888 · 2023-12-21

申請人Suzhou Haishen Medical Device Associates Co., Ltd.

決定日期2023-12-21

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

Disposable Laryngeal Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K232888. 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 Disposable Laryngeal Electrodes?

Disposable Laryngeal Electrodes is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. The 510(k) number is K232888.

When did Disposable Laryngeal Electrodes receive FDA 510(k) clearance?

Disposable Laryngeal Electrodes received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232888.

Who is the listed applicant for Disposable Laryngeal Electrodes?

The FDA 510(k) record lists Suzhou Haishen Medical Device Associates Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Laryngeal Electrodes?

The FDA product code for Disposable Laryngeal Electrodes is ETN.

其他以 Suzhou Haishen Medical Device Associates Co., Ltd. 為申請人之記錄

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K232581醫療一次性无菌針電極

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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