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FDA 510(k)

GR膠質系統 MSI

K 號：K231775 · 2024-08-08

申請人Pro3Dure Medical
決定日期2024-08-08
產品代碼MQC
決定相當於

器材摘要

GR Resin System MSI is the device name listed in this FDA 510(k) record. The listed applicant is Pro3Dure Medical. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K231775. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the GR Resin System MSI?

GR Resin System MSI is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Pro3Dure Medical. The 510(k) number is K231775.

When did GR Resin System MSI receive FDA 510(k) clearance?

GR Resin System MSI received FDA 510(k) clearance on 2024-08-08, under 510(k) number K231775.

Who is the listed applicant for GR Resin System MSI?

The FDA 510(k) record lists Pro3Dure Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GR Resin System MSI?

The FDA product code for GR Resin System MSI is MQC.

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：MQC）

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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