FDA 510(k)

Eko分析軟體

K 號：K192004 · 2020-01-15

決定日期2020-01-15

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

Eko Analysis Software 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 2020-01-15 under 510(k) number K192004. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Eko Analysis Software?

Eko Analysis Software is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Eko Devices, Inc.. The 510(k) number is K192004.

When did Eko Analysis Software receive FDA 510(k) clearance?

Eko Analysis Software received FDA 510(k) clearance on 2020-01-15, under 510(k) number K192004.

Who is the listed applicant for Eko Analysis Software?

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 Analysis Software?

The FDA product code for Eko Analysis Software is MWI.

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。

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相關器械（代碼：MWI）

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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