FDA 510(k)

Matrix Mini 心電圖監護器

K 號：K152701 · 2016-04-22

決定日期2016-04-22

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

Matrix Mini ECG Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Global Instrumentation, LLC. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K152701. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Matrix Mini ECG Monitor?

Matrix Mini ECG Monitor is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Global Instrumentation, LLC. The 510(k) number is K152701.

When did Matrix Mini ECG Monitor receive FDA 510(k) clearance?

Matrix Mini ECG Monitor received FDA 510(k) clearance on 2016-04-22, under 510(k) number K152701.

Who is the listed applicant for Matrix Mini ECG Monitor?

The FDA 510(k) record lists Global Instrumentation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Matrix Mini ECG Monitor?

The FDA product code for Matrix Mini ECG Monitor is DSI.

其他以 Global Instrumentation, LLC 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。

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相關器械（代碼：DSI）

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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