FDA 510(k)

美敦力型號 53401 外部脈衝發生器（EPG）

K 號：K180873 · 2018-04-19

決定日期2018-04-19

產品代碼DTE

諮詢委員會履歷

決定相當於

器材摘要

Medtronic Model 53401 External Pulse Generator (EPG) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180873. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medtronic Model 53401 External Pulse Generator (EPG)?

Medtronic Model 53401 External Pulse Generator (EPG) is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Medtronic, Inc.. The 510(k) number is K180873.

When did Medtronic Model 53401 External Pulse Generator (EPG) receive FDA 510(k) clearance?

Medtronic Model 53401 External Pulse Generator (EPG) received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180873.

Who is the listed applicant for Medtronic Model 53401 External Pulse Generator (EPG)?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Medtronic Model 53401 External Pulse Generator (EPG)?

The FDA product code for Medtronic Model 53401 External Pulse Generator (EPG) is DTE.

其他以 Medtronic, 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：DTE）

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。

K241781單獨節拍控制Solo Pace, Inc.K232721Lifetech 心臟臨時起搏器Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011美敦力型號 5392 外部脈衝發生器（EPG）Medtronic, Inc.K190825美敦力型號 5392 外部脈衝發生器（EPG）Medtronic, Inc.K182839Lifetech 心臟模型 8301 暫時性起搏器Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973美敦力型號 5392 外部脈衝發生器（EPG）Medtronic, Inc.

官方來源

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