FDA 510(k)

CardioLogs 心電圖分析平台

K 號：K170568 · 2017-06-26

決定日期2017-06-26

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

CardioLogs ECG Analysis Platform is the device name listed in this FDA 510(k) record. The listed applicant is Cardiologs Technologies. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K170568. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CardioLogs ECG Analysis Platform?

CardioLogs ECG Analysis Platform is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Cardiologs Technologies. The 510(k) number is K170568.

When did CardioLogs ECG Analysis Platform receive FDA 510(k) clearance?

CardioLogs ECG Analysis Platform received FDA 510(k) clearance on 2017-06-26, under 510(k) number K170568.

Who is the listed applicant for CardioLogs ECG Analysis Platform?

The FDA 510(k) record lists Cardiologs Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioLogs ECG Analysis Platform?

The FDA product code for CardioLogs ECG Analysis Platform is DPS.

其他以 Cardiologs Technologies 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。

K212112Cardiologs 霍爾特平台

相關器械（代碼：DPS）

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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