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FDA 510(k)

Copra Supreme

K 號:K233064 · 2024-09-18

決定日期2024-09-18
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

Copra Supreme is the device name listed in this FDA 510(k) record. The listed applicant is Whitepeaks Dental Solutions GmbH. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K233064. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Copra Supreme?

Copra Supreme is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Whitepeaks Dental Solutions GmbH. The 510(k) number is K233064.

When did Copra Supreme receive FDA 510(k) clearance?

Copra Supreme received FDA 510(k) clearance on 2024-09-18, under 510(k) number K233064.

Who is the listed applicant for Copra Supreme?

The FDA 510(k) record lists Whitepeaks Dental Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Copra Supreme?

The FDA product code for Copra Supreme is EIH.

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。

其他以 Whitepeaks Dental Solutions GmbH 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。

相關器械(代碼:EIH)

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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