FDA 510(k)

VV330 持續心電圖平台，VivaLNK 粘貼片

K 號：K191870 · 2020-01-07

決定日期2020-01-07

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is the device name listed in this FDA 510(k) record. The listed applicant is VivaLNK, Inc.. It received FDA 510(k) clearance on 2020-01-07 under 510(k) number K191870. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VV330 Continuous ECG Platform, VivaLNK Adhesive Patch?

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is a medical device that received FDA 510(k) clearance on 2020-01-07. The listed applicant is VivaLNK, Inc.. The 510(k) number is K191870.

When did VV330 Continuous ECG Platform, VivaLNK Adhesive Patch receive FDA 510(k) clearance?

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch received FDA 510(k) clearance on 2020-01-07, under 510(k) number K191870.

Who is the listed applicant for VV330 Continuous ECG Platform, VivaLNK Adhesive Patch?

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

What is the FDA product code for VV330 Continuous ECG Platform, VivaLNK Adhesive Patch?

The FDA product code for VV330 Continuous ECG Platform, VivaLNK Adhesive Patch is DRG.

其他以 VivaLNK, Inc. 為申請人之記錄

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相關器械（代碼：DRG）

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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