FDA 510(k)

麥斯特羅平台

K 號：K221410 · 2022-12-02

決定日期2022-12-02

產品代碼FQO

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

Maestro Platform is the device name listed in this FDA 510(k) record. The listed applicant is Moon Surgical. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221410. The device is classified under product code FQO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Maestro Platform?

Maestro Platform is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Moon Surgical. The 510(k) number is K221410.

When did Maestro Platform receive FDA 510(k) clearance?

Maestro Platform received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221410.

Who is the listed applicant for Maestro Platform?

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

What is the FDA product code for Maestro Platform?

The FDA product code for Maestro Platform is FQO.

其他以 Moon Surgical 為申請人之記錄

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。

K250984麥斯特系統（REF100）K242323麥斯特系統（REF100）K240598麥斯特系統（REF100）

相關器械（代碼：FQO）

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。

K240598麥斯特系統（REF100）Moon Surgical

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。