FDA 510(k)

Epicardia 任何處

K 號：K173170 · 2018-01-10

決定日期2018-01-10

產品代碼DSI

諮詢委員會履歷

決定相當於

器材摘要

Epicardia Anywhere is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K173170. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Epicardia Anywhere?

Epicardia Anywhere is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Medicomp, Inc.. The 510(k) number is K173170.

When did Epicardia Anywhere receive FDA 510(k) clearance?

Epicardia Anywhere received FDA 510(k) clearance on 2018-01-10, under 510(k) number K173170.

Who is the listed applicant for Epicardia Anywhere?

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

What is the FDA product code for Epicardia Anywhere?

The FDA product code for Epicardia Anywhere is DSI.

其他以 Medicomp, Inc. 為申請人之記錄

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相關器械（代碼：DSI）

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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