幻影三部曲
K 號：K213534 · 2022-03-11
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器材摘要
PHantom Trilogy is the device name listed in this FDA 510(k) record. The listed applicant is Resurgeonz, LLC. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213534. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PHantom Trilogy?
PHantom Trilogy is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Resurgeonz, LLC. The 510(k) number is K213534.
When did PHantom Trilogy receive FDA 510(k) clearance?
PHantom Trilogy received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213534.
Who is the listed applicant for PHantom Trilogy?
The FDA 510(k) record lists Resurgeonz, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PHantom Trilogy?
The FDA product code for PHantom Trilogy is OLI.
相關臨床試驗
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相關器械（代碼：OLI）
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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