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FDA 510(k)

NES再處理RF風針(RFS)

K 號:K173214 · 2018-03-27

決定日期2018-03-27
產品代碼NUJ
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

NES Reprocessed RF Stylet (RFS) is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc. (Nes). It received FDA 510(k) clearance on 2018-03-27 under 510(k) number K173214. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NES Reprocessed RF Stylet (RFS)?

NES Reprocessed RF Stylet (RFS) is a medical device that received FDA 510(k) clearance on 2018-03-27. The listed applicant is Northeast Scientific, Inc. (Nes). The 510(k) number is K173214.

When did NES Reprocessed RF Stylet (RFS) receive FDA 510(k) clearance?

NES Reprocessed RF Stylet (RFS) received FDA 510(k) clearance on 2018-03-27, under 510(k) number K173214.

Who is the listed applicant for NES Reprocessed RF Stylet (RFS)?

The FDA 510(k) record lists Northeast Scientific, Inc. (Nes) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NES Reprocessed RF Stylet (RFS)?

The FDA product code for NES Reprocessed RF Stylet (RFS) is NUJ.

相關臨床試驗

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相關器械(代碼:NUJ)

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

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