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FDA 510(k)

ArthroFree 遥控外科攝影系統

K 號:K213860 · 2022-03-23

決定日期2022-03-23
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

ArthroFree Wireless Surgical Camera System is the device name listed in this FDA 510(k) record. The listed applicant is Lazurite Holdings, LLC. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K213860. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ArthroFree Wireless Surgical Camera System?

ArthroFree Wireless Surgical Camera System is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Lazurite Holdings, LLC. The 510(k) number is K213860.

When did ArthroFree Wireless Surgical Camera System receive FDA 510(k) clearance?

ArthroFree Wireless Surgical Camera System received FDA 510(k) clearance on 2022-03-23, under 510(k) number K213860.

Who is the listed applicant for ArthroFree Wireless Surgical Camera System?

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

What is the FDA product code for ArthroFree Wireless Surgical Camera System?

The FDA product code for ArthroFree Wireless Surgical Camera System is GCJ.

相關臨床試驗

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相關器械(代碼:GCJ)

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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