FDA 510(k)

cmAngio® V1.0

K 號：K232367 · 2023-10-05

決定日期2023-10-05

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

cmAngio® V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Curemetrix, Inc.. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K232367. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the cmAngio® V1.0?

cmAngio® V1.0 is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Curemetrix, Inc.. The 510(k) number is K232367.

When did cmAngio® V1.0 receive FDA 510(k) clearance?

cmAngio® V1.0 received FDA 510(k) clearance on 2023-10-05, under 510(k) number K232367.

Who is the listed applicant for cmAngio® V1.0?

FDA 510(k) 記錄將 Curemetrix, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for cmAngio® V1.0?

The FDA product code for cmAngio® V1.0 is QIH.

其他以 Curemetrix, Inc. 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。

K260980cmAngio® V2.0 K250754cmAngio® (V1.6)K183285cmTriage 注意：根據政策「medical-regulatory-v1」，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址應保持不變。上述翻譯中，已保留所有指定不變的元素。

相關器械（代碼：QIH）

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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