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FDA 510(k)

拉茲神經統計RF發生器

K 號:K232632 · 2024-05-24

決定日期2024-05-24
產品代碼GXD
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Racz Neurostat RF Generator is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K232632. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Racz Neurostat RF Generator?

Racz Neurostat RF Generator is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Epimed International. The 510(k) number is K232632.

When did Racz Neurostat RF Generator receive FDA 510(k) clearance?

Racz Neurostat RF Generator received FDA 510(k) clearance on 2024-05-24, under 510(k) number K232632.

Who is the listed applicant for Racz Neurostat RF Generator?

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

What is the FDA product code for Racz Neurostat RF Generator?

The FDA product code for Racz Neurostat RF Generator is GXD.

相關臨床試驗

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相關器械(代碼:GXD)

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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