FDA 510(k)

單獨節拍控制

K 號：K241781 · 2025-01-10

決定日期2025-01-10

產品代碼DTE

諮詢委員會履歷

決定相當於

器材摘要

Solo Pace Control is the device name listed in this FDA 510(k) record. The listed applicant is Solo Pace, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241781. 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 Solo Pace Control?

Solo Pace Control is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Solo Pace, Inc.. The 510(k) number is K241781.

When did Solo Pace Control receive FDA 510(k) clearance?

Solo Pace Control received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241781.

Who is the listed applicant for Solo Pace Control?

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

What is the FDA product code for Solo Pace Control?

The FDA product code for Solo Pace Control is DTE.

其他以 Solo Pace, 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。

K252674獨步節奏融合系統（SOLOFUSE1）

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。

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.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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