FDA 510(k)

G-CAM

K 號：K220329 · 2022-08-16

決定日期2022-08-16

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

G-CAM is the device name listed in this FDA 510(k) record. The listed applicant is Graphenano Dental S.L.. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K220329. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the G-CAM?

G-CAM is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Graphenano Dental S.L.. The 510(k) number is K220329.

When did G-CAM receive FDA 510(k) clearance?

G-CAM received FDA 510(k) clearance on 2022-08-16, under 510(k) number K220329.

Who is the listed applicant for G-CAM?

The FDA 510(k) record lists Graphenano Dental S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-CAM?

The FDA product code for G-CAM is EBF.

其他以 Graphenano Dental S.L. 為申請人之記錄

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。

K253236G-BLOCK

相關器械（代碼：EBF）

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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