ExoAtlet-II
K 號：K201473 · 2021-07-16
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器材摘要
ExoAtlet-II is the device name listed in this FDA 510(k) record. The listed applicant is Exoatlet Asia Co. , Ltd.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K201473. 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 ExoAtlet-II?
ExoAtlet-II is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Exoatlet Asia Co. , Ltd.. The 510(k) number is K201473.
When did ExoAtlet-II receive FDA 510(k) clearance?
ExoAtlet-II received FDA 510(k) clearance on 2021-07-16, under 510(k) number K201473.
Who is the listed applicant for ExoAtlet-II?
The FDA 510(k) record lists Exoatlet Asia Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ExoAtlet-II?
The FDA product code for ExoAtlet-II is PHL.
相關臨床試驗
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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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