精巧II
K 號：K251083 · 2025-09-12
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器材摘要
Compact II is the device name listed in this FDA 510(k) record. The listed applicant is Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K251083. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Compact II?
Compact II is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Enraf-Nonius, B.V.. The 510(k) number is K251083.
When did Compact II receive FDA 510(k) clearance?
Compact II received FDA 510(k) clearance on 2025-09-12, under 510(k) number K251083.
Who is the listed applicant for Compact II?
The FDA 510(k) record lists Enraf-Nonius, B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Compact II?
The FDA product code for Compact II is IPF.
相關臨床試驗
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其他以 Enraf-Nonius, B.V. 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。
相關器械（代碼：IPF）
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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