SurBlate 摧毁系統
K 號：K223272 · 2023-02-28
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器材摘要
SurBlate Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Mima-Pro Scientific, Inc.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K223272. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SurBlate Ablation System?
SurBlate Ablation System is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Mima-Pro Scientific, Inc.. The 510(k) number is K223272.
When did SurBlate Ablation System receive FDA 510(k) clearance?
SurBlate Ablation System received FDA 510(k) clearance on 2023-02-28, under 510(k) number K223272.
Who is the listed applicant for SurBlate Ablation System?
The FDA 510(k) record lists Mima-Pro Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SurBlate Ablation System?
The FDA product code for SurBlate Ablation System is NEY.
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：NEY）
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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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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