鳳凰
K 號:K183152 · 2019-04-17
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器材摘要
Phoenix is the device name listed in this FDA 510(k) record. The listed applicant is Us Bionics, Inc. (Dba Suitx). It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K183152. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Phoenix?
Phoenix is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Us Bionics, Inc. (Dba Suitx). The 510(k) number is K183152.
When did Phoenix receive FDA 510(k) clearance?
Phoenix received FDA 510(k) clearance on 2019-04-17, under 510(k) number K183152.
Who is the listed applicant for Phoenix?
The FDA 510(k) record lists Us Bionics, Inc. (Dba Suitx) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Phoenix?
The FDA product code for Phoenix is PHL.
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。
相關器械(代碼:PHL)
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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