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FDA 510(k)

Lumos 3DX

K 號：K223780 · 2023-07-06

申請人3Dio
決定日期2023-07-06
產品代碼EHD
諮詢委員會DE
決定相當於

器材摘要

Lumos 3DX is the device name listed in this FDA 510(k) record. The listed applicant is 3Dio. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K223780. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lumos 3DX?

Lumos 3DX is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is 3Dio. The 510(k) number is K223780.

When did Lumos 3DX receive FDA 510(k) clearance?

Lumos 3DX received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223780.

Who is the listed applicant for Lumos 3DX?

The FDA 510(k) record lists 3Dio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumos 3DX?

The FDA product code for Lumos 3DX is EHD.

相關臨床試驗

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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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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官方來源

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