FDA 510(k)

純EP

K 號：K180805 · 2018-08-08

決定日期2018-08-08

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Pure EP is the device name listed in this FDA 510(k) record. The listed applicant is Biosig Technologies. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K180805. 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 Pure EP?

Pure EP is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Biosig Technologies. The 510(k) number is K180805.

When did Pure EP receive FDA 510(k) clearance?

Pure EP received FDA 510(k) clearance on 2018-08-08, under 510(k) number K180805.

Who is the listed applicant for Pure EP?

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

What is the FDA product code for Pure EP?

The FDA product code for Pure EP is DQK.

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。

K261729EnSite™ X EP 系統Abbott Medical K262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston Scientific K253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott Medical K252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

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