免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Fixtemp® C&B 4:1

K 號：K241226 · 2024-05-31

申請人Dreve Denatmid GmbH
決定日期2024-05-31
產品代碼EBG
諮詢委員會DE
決定相當於

器材摘要

Fixtemp® C&B 4:1 is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Denatmid GmbH. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K241226. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fixtemp® C&B 4:1?

Fixtemp® C&B 4:1 is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Dreve Denatmid GmbH. The 510(k) number is K241226.

When did Fixtemp® C&B 4:1 receive FDA 510(k) clearance?

Fixtemp® C&B 4:1 received FDA 510(k) clearance on 2024-05-31, under 510(k) number K241226.

Who is the listed applicant for Fixtemp® C&B 4:1?

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

What is the FDA product code for Fixtemp® C&B 4:1?

The FDA product code for Fixtemp® C&B 4:1 is EBG.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：EBG）

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。

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基座”及“FLNT 溫度”Liaoning Upcera Co., Ltd.K251271TempFIT 暫時冠橋膠Rizhao Huge Biomaterials Company, Ltd.K243370牙齒牙齒Asiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER，基於PMMA的牙科树脂Taiwan Dental Materials Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑