FDA 510(k)

Vektor計算機心電圖映射系統（vMap）

K 號：K211546 · 2021-11-09

決定日期2021-11-09

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Vektor Computational ECG Mapping System (vMap) is the device name listed in this FDA 510(k) record. The listed applicant is Vektor Medical, Inc.. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211546. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vektor Computational ECG Mapping System (vMap)?

Vektor Computational ECG Mapping System (vMap) is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Vektor Medical, Inc.. The 510(k) number is K211546.

When did Vektor Computational ECG Mapping System (vMap) receive FDA 510(k) clearance?

Vektor Computational ECG Mapping System (vMap) received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211546.

Who is the listed applicant for Vektor Computational ECG Mapping System (vMap)?

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

What is the FDA product code for Vektor Computational ECG Mapping System (vMap)?

The FDA product code for Vektor Computational ECG Mapping System (vMap) is DQK.

其他以 Vektor Medical, 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。

K252429Vektor計算機心電圖映射系統（vMap®）

相關器械（代碼：DQK）

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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