FDA 510(k)

統一心律失常診斷系統口袋心電圖IV

K 號：K193104 · 2020-04-09

決定日期2020-04-09

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

Unified Arrhythmia Diagnostic System PocketECG IV is the device name listed in this FDA 510(k) record. The listed applicant is Medicalgorithmics S.A.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K193104. 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 Unified Arrhythmia Diagnostic System PocketECG IV?

Unified Arrhythmia Diagnostic System PocketECG IV is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Medicalgorithmics S.A.. The 510(k) number is K193104.

When did Unified Arrhythmia Diagnostic System PocketECG IV receive FDA 510(k) clearance?

Unified Arrhythmia Diagnostic System PocketECG IV received FDA 510(k) clearance on 2020-04-09, under 510(k) number K193104.

Who is the listed applicant for Unified Arrhythmia Diagnostic System PocketECG IV?

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

What is the FDA product code for Unified Arrhythmia Diagnostic System PocketECG IV?

The FDA product code for Unified Arrhythmia Diagnostic System PocketECG IV is DSI.

其他以 Medicalgorithmics S.A. 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。

K253141DeepRhythmAI 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URLs應保持不變。上述翻譯中，已保留所有指定不變的元素。K250932DeepRhythmAI 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URLs應保持不變。上述翻譯中，已保留所有指定不變的元素。K241197DeepRhythmAI 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URLs應保持不變。上述翻譯中，已保留所有指定不變的元素。K232161DeepRhythm 平臺 K210822DeepRhythmAI 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URLs應保持不變。上述翻譯中，已保留所有指定不變的元素。K210758Q 貼片

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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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