FDA 510(k)

Lifetech 心臟臨時起搏器

K 號：K232721 · 2024-01-07

申請人Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

決定日期2024-01-07

產品代碼DTE

諮詢委員會履歷

決定相當於

器材摘要

Lifetech Cardio Temporary Pacemaker is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-01-07 under 510(k) number K232721. 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 Lifetech Cardio Temporary Pacemaker?

Lifetech Cardio Temporary Pacemaker is a medical device that received FDA 510(k) clearance on 2024-01-07. The listed applicant is Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. The 510(k) number is K232721.

When did Lifetech Cardio Temporary Pacemaker receive FDA 510(k) clearance?

Lifetech Cardio Temporary Pacemaker received FDA 510(k) clearance on 2024-01-07, under 510(k) number K232721.

Who is the listed applicant for Lifetech Cardio Temporary Pacemaker?

The FDA 510(k) record lists Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lifetech Cardio Temporary Pacemaker?

The FDA product code for Lifetech Cardio Temporary Pacemaker is DTE.

其他以 Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. 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。

K182839Lifetech 心臟模型 8301 暫時性起搏器

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.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.K180873美敦力型號 53401 外部脈衝發生器（EPG）Medtronic, Inc.

官方來源

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