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FDA 510(k)

7D 外科系統 - 皮內應用 (7D Flash Frame)

K 號:K220522 · 2022-05-20

申請人7D Surgical
決定日期2022-05-20
產品代碼OLO
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

7D Surgical System - Percutaneous Application (7D Flash Frame) is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K220522. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 7D Surgical System - Percutaneous Application (7D Flash Frame)?

7D Surgical System - Percutaneous Application (7D Flash Frame) is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is 7D Surgical. The 510(k) number is K220522.

When did 7D Surgical System - Percutaneous Application (7D Flash Frame) receive FDA 510(k) clearance?

7D Surgical System - Percutaneous Application (7D Flash Frame) received FDA 510(k) clearance on 2022-05-20, under 510(k) number K220522.

Who is the listed applicant for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

The FDA 510(k) record lists 7D Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

The FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame) is OLO.

相關臨床試驗

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相關器械(代碼:OLO)

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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