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FDA 510(k)

Athena 外科 RMUS 系統

K 號：K210087 · 2021-04-12

申請人Athena Surgical, LLC
決定日期2021-04-12
產品代碼OTN
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

Athena Surgical RMUS System is the device name listed in this FDA 510(k) record. The listed applicant is Athena Surgical, LLC. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K210087. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Athena Surgical RMUS System?

Athena Surgical RMUS System is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Athena Surgical, LLC. The 510(k) number is K210087.

When did Athena Surgical RMUS System receive FDA 510(k) clearance?

Athena Surgical RMUS System received FDA 510(k) clearance on 2021-04-12, under 510(k) number K210087.

Who is the listed applicant for Athena Surgical RMUS System?

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

What is the FDA product code for Athena Surgical RMUS System?

The FDA product code for Athena Surgical RMUS System is OTN.

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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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