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FDA 510(k)

EasyMap MAP 管針

K 號：K151139 · 2016-10-18

申請人Medfact Engineering GmbH
決定日期2016-10-18
產品代碼DRF
諮詢委員會履歷
決定相當於

器材摘要

EasyMap MAP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medfact Engineering GmbH. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K151139. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EasyMap MAP Catheter?

EasyMap MAP Catheter is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Medfact Engineering GmbH. The 510(k) number is K151139.

When did EasyMap MAP Catheter receive FDA 510(k) clearance?

EasyMap MAP Catheter received FDA 510(k) clearance on 2016-10-18, under 510(k) number K151139.

Who is the listed applicant for EasyMap MAP Catheter?

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

What is the FDA product code for EasyMap MAP Catheter?

The FDA product code for EasyMap MAP Catheter is DRF.

相關臨床試驗

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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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