FDA 510(k)

ScioCardio 心電傳送器

K 號：K171019 · 2018-05-30

決定日期2018-05-30

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

ScioCardio ECG Transmitter is the device name listed in this FDA 510(k) record. The listed applicant is Synergen Technology Labs, LLC. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K171019. 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 ScioCardio ECG Transmitter?

ScioCardio ECG Transmitter is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Synergen Technology Labs, LLC. The 510(k) number is K171019.

When did ScioCardio ECG Transmitter receive FDA 510(k) clearance?

ScioCardio ECG Transmitter received FDA 510(k) clearance on 2018-05-30, under 510(k) number K171019.

Who is the listed applicant for ScioCardio ECG Transmitter?

The FDA 510(k) record lists Synergen Technology Labs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ScioCardio ECG Transmitter?

The FDA product code for ScioCardio ECG Transmitter is DRG.

其他以 Synergen Technology Labs, LLC 為申請人之記錄

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K252978ScioCardio 心電圖分析平台

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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官方來源

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