FDA 510(k)

FIRMap 穿刺針

K 號：K163709 · 2017-02-28

決定日期2017-02-28

產品代碼MTD

諮詢委員會履歷

決定相當於

器材摘要

FIRMap Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Electrophysiology. It received FDA 510(k) clearance on 2017-02-28 under 510(k) number K163709. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FIRMap Catheter?

FIRMap Catheter is a medical device that received FDA 510(k) clearance on 2017-02-28. The listed applicant is Abbott Electrophysiology. The 510(k) number is K163709.

When did FIRMap Catheter receive FDA 510(k) clearance?

FIRMap Catheter received FDA 510(k) clearance on 2017-02-28, under 510(k) number K163709.

Who is the listed applicant for FIRMap Catheter?

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

What is the FDA product code for FIRMap Catheter?

The FDA product code for FIRMap Catheter is MTD.

其他以 Abbott Electrophysiology 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。

K171583節律視工作站 K161240節奏視覺工作站（非串流）K153093FIRMap 穿刺針

相關器械（代碼：MTD）

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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