Aurora
K 號：K231355 · 2024-02-09
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器材摘要
Aurora is the device name listed in this FDA 510(k) record. The listed applicant is Ensodata. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K231355. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Aurora?
Aurora is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Ensodata. The 510(k) number is K231355.
When did Aurora receive FDA 510(k) clearance?
Aurora received FDA 510(k) clearance on 2024-02-09, under 510(k) number K231355.
Who is the listed applicant for Aurora?
The FDA 510(k) record lists Ensodata as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aurora?
The FDA product code for Aurora is MNR.
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相關器械（代碼：MNR）
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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