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FDA 510(k)

心電圖檢查 - 適用型，心電圖檢查 - 適用型加強版

K 號：K170506 · 2017-10-02

申請人Cardiac Designs, Inc.
決定日期2017-10-02
產品代碼DXH
諮詢委員會履歷
決定相當於

器材摘要

ECG Check - Universal, ECG Check - Universal Plus is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Designs, Inc.. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K170506. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the ECG Check - Universal, ECG Check - Universal Plus?

ECG Check - Universal, ECG Check - Universal Plus is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Cardiac Designs, Inc.. The 510(k) number is K170506.

When did ECG Check - Universal, ECG Check - Universal Plus receive FDA 510(k) clearance?

ECG Check - Universal, ECG Check - Universal Plus received FDA 510(k) clearance on 2017-10-02, under 510(k) number K170506.

Who is the listed applicant for ECG Check - Universal, ECG Check - Universal Plus?

The FDA 510(k) record lists Cardiac Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Check - Universal, ECG Check - Universal Plus?

The FDA product code for ECG Check - Universal, ECG Check - Universal Plus is DXH. This falls under the Hematology category.

相關臨床試驗

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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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