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FDA 510(k)

烏爾里希注射CT動態

K 號：K192872 · 2020-07-02

申請人Ulrich GmbH & Co. KG
決定日期2020-07-02
產品代碼IZQ
諮詢委員會履歷
決定相當於

器材摘要

ulrichINJECT CT Motion is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192872. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ulrichINJECT CT Motion?

ulrichINJECT CT Motion is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K192872.

When did ulrichINJECT CT Motion receive FDA 510(k) clearance?

ulrichINJECT CT Motion received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192872.

Who is the listed applicant for ulrichINJECT CT Motion?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ulrichINJECT CT Motion?

The FDA product code for ulrichINJECT CT Motion is IZQ.

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

其他以 Ulrich GmbH & Co. KG 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。

K252281ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)K251295烏爾里希注射CT動態 (XD 8000)K241850ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)K210541烏爾里希注射CT移動K202227Artus™ cervical plate system

查看所有 11 項裝置 →

相關器械（代碼：IZQ）

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。

K262115VueJect® 超聲波增強劑輸送系統ACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295烏爾里希注射CT動態 (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT注射系統；MEDRAD Centargo日設；MEDRAD Centargo病人線；MEDRAD Centargo替換針頭；MEDRAD ISI2模組（ISI2）Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT注射系統；MEDRAD Centargo日設；MEDRAD Centargo病人線；MEDRAD Centargo替換針頭；MEDRAD ISI2模組（ISI2）Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

官方來源

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