FDA 510(k)

Voyant精融設備（EB230）

K 號：K202818 · 2021-12-16

決定日期2021-12-16

產品代碼GEI

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

Voyant Fine Fusion Device (EB230) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K202818. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Voyant Fine Fusion Device (EB230)?

Voyant Fine Fusion Device (EB230) is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Applied Medical. The 510(k) number is K202818.

When did Voyant Fine Fusion Device (EB230) receive FDA 510(k) clearance?

Voyant Fine Fusion Device (EB230) received FDA 510(k) clearance on 2021-12-16, under 510(k) number K202818.

Who is the listed applicant for Voyant Fine Fusion Device (EB230)?

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

What is the FDA product code for Voyant Fine Fusion Device (EB230)?

The FDA product code for Voyant Fine Fusion Device (EB230) is GEI.

其他以 Applied Medical 為申請人之記錄

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相關器械（代碼：GEI）

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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