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FDA 510(k)

法斯對齊系統

K 號:K242929 · 2024-12-20

決定日期2024-12-20
產品代碼NXC
諮詢委員會DE
決定相當於

器材摘要

Fas Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Xplora 3D Europe S.L. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242929. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fas Aligner System?

Fas Aligner System is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Xplora 3D Europe S.L. The 510(k) number is K242929.

When did Fas Aligner System receive FDA 510(k) clearance?

Fas Aligner System received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242929.

Who is the listed applicant for Fas Aligner System?

The FDA 510(k) record lists Xplora 3D Europe S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fas Aligner System?

The FDA product code for Fas Aligner System is NXC.

相關臨床試驗

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相關器械(代碼:NXC)

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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