基因奧X精英
K 號：K233766 · 2024-05-07
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器材摘要
Geneo X Elite is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K233766. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Geneo X Elite?
Geneo X Elite is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Pollogen, Ltd.. The 510(k) number is K233766.
When did Geneo X Elite receive FDA 510(k) clearance?
Geneo X Elite received FDA 510(k) clearance on 2024-05-07, under 510(k) number K233766.
Who is the listed applicant for Geneo X Elite?
The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Geneo X Elite?
The FDA product code for Geneo X Elite is PAY.
相關臨床試驗
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其他以 Pollogen, Ltd. 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：PAY）
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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