OneStim-DUO 心臟刺激器 (MP5003-4CO)
K 號：K253088 · 2026-06-12
廣告
器材摘要
OneStim-DUO Cardiac Stimulator (MP5003-4CO) is the device name listed in this FDA 510(k) record. The listed applicant is Micropace Pty, Ltd.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253088. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OneStim-DUO Cardiac Stimulator (MP5003-4CO)?
OneStim-DUO Cardiac Stimulator (MP5003-4CO) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Micropace Pty, Ltd.. The 510(k) number is K253088.
When did OneStim-DUO Cardiac Stimulator (MP5003-4CO) receive FDA 510(k) clearance?
OneStim-DUO Cardiac Stimulator (MP5003-4CO) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253088.
Who is the listed applicant for OneStim-DUO Cardiac Stimulator (MP5003-4CO)?
The FDA 510(k) record lists Micropace Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OneStim-DUO Cardiac Stimulator (MP5003-4CO)?
The FDA product code for OneStim-DUO Cardiac Stimulator (MP5003-4CO) is DQK.
相關臨床試驗
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。
相關器械（代碼：DQK）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告