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FDA 510(k)

Vesta 電波針管

K 號:K190259 · 2020-02-07

申請人Biomerics
決定日期2020-02-07
產品代碼GXI
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

Vesta RF Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Biomerics. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K190259. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vesta RF Cannula?

Vesta RF Cannula is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Biomerics. The 510(k) number is K190259.

When did Vesta RF Cannula receive FDA 510(k) clearance?

Vesta RF Cannula received FDA 510(k) clearance on 2020-02-07, under 510(k) number K190259.

Who is the listed applicant for Vesta RF Cannula?

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

What is the FDA product code for Vesta RF Cannula?

The FDA product code for Vesta RF Cannula is GXI.

相關臨床試驗

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相關器械(代碼:GXI)

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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