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FDA 510(k)

LEGAACY® IPC

K 號：K232006 · 2023-08-04

申請人Ig Technology, Ltd.
決定日期2023-08-04
產品代碼JOW
諮詢委員會履歷
決定相當於

器材摘要

LEGACY® IPC is the device name listed in this FDA 510(k) record. The listed applicant is Ig Technology, Ltd.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K232006. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LEGACY® IPC?

LEGACY® IPC is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Ig Technology, Ltd.. The 510(k) number is K232006.

When did LEGACY® IPC receive FDA 510(k) clearance?

LEGACY® IPC received FDA 510(k) clearance on 2023-08-04, under 510(k) number K232006.

Who is the listed applicant for LEGACY® IPC?

The FDA 510(k) record lists Ig Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGACY® IPC?

The FDA product code for LEGACY® IPC is JOW.

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：JOW）

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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