Facet Aurora 可重用針頭底座
K 號：K232912 · 2024-01-25
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器材摘要
Facet Aurora Reusable Lancet Base is the device name listed in this FDA 510(k) record. The listed applicant is Facet Technologies, LLC. It received FDA 510(k) clearance on 2024-01-25 under 510(k) number K232912. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Facet Aurora Reusable Lancet Base?
Facet Aurora Reusable Lancet Base is a medical device that received FDA 510(k) clearance on 2024-01-25. The listed applicant is Facet Technologies, LLC. The 510(k) number is K232912.
When did Facet Aurora Reusable Lancet Base receive FDA 510(k) clearance?
Facet Aurora Reusable Lancet Base received FDA 510(k) clearance on 2024-01-25, under 510(k) number K232912.
Who is the listed applicant for Facet Aurora Reusable Lancet Base?
The FDA 510(k) record lists Facet Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Facet Aurora Reusable Lancet Base?
The FDA product code for Facet Aurora Reusable Lancet Base is QRL.
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。
其他以 Facet Technologies, LLC 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：QRL）
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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