FDA 510(k)

Eko CORE

K 號：K200776 · 2020-04-06

決定日期2020-04-06

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Eko CORE is the device name listed in this FDA 510(k) record. The listed applicant is Eko Devices, Inc.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K200776. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eko CORE?

Eko CORE is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Eko Devices, Inc.. The 510(k) number is K200776.

When did Eko CORE receive FDA 510(k) clearance?

Eko CORE received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200776.

Who is the listed applicant for Eko CORE?

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

What is the FDA product code for Eko CORE?

The FDA product code for Eko CORE is DQD.

其他以 Eko Devices, 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。

K230111核心500數位聽診器 K213794Eko低聲分析軟體（EMAS）K192004Eko分析軟體 K170874Eko Model E5 系統（EME5），Eko DUO

相關器械（代碼：DQD）

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。

K261494智慧無線聽診器（STEMO310）；智慧無線聽診器（STEMO710）；智慧無線聽診器（STEMO720）；智慧無線聽診器（STEMO730）Shanghai Hulu Devices Co., Ltd.K261694核心300數位聽診器Eko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089泰托聽診器（G3）Tyto Care , Ltd.K252076膝聲軟骨評估系統（750-3600-001）Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。