醫療設備規範文本翻譯： PhysCade 系統
K 號：K250749 · 2025-06-04
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器材摘要
PhysCade System is the device name listed in this FDA 510(k) record. The listed applicant is Physcade, Inc.. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K250749. 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 PhysCade System?
PhysCade System is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Physcade, Inc.. The 510(k) number is K250749.
When did PhysCade System receive FDA 510(k) clearance?
PhysCade System received FDA 510(k) clearance on 2025-06-04, under 510(k) number K250749.
Who is the listed applicant for PhysCade System?
The FDA 510(k) record lists Physcade, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PhysCade System?
The FDA product code for PhysCade System is DQK.
相關臨床試驗
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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。
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