Apollo Duet (型號：APD-4000)
K 號：K212253 · 2022-08-25
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器材摘要
Apollo Duet (Model : APD-4000) is the device name listed in this FDA 510(k) record. The listed applicant is Weero Co.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K212253. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Apollo Duet (Model : APD-4000)?
Apollo Duet (Model : APD-4000) is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Weero Co.. The 510(k) number is K212253.
When did Apollo Duet (Model : APD-4000) receive FDA 510(k) clearance?
Apollo Duet (Model : APD-4000) received FDA 510(k) clearance on 2022-08-25, under 510(k) number K212253.
Who is the listed applicant for Apollo Duet (Model : APD-4000)?
The FDA 510(k) record lists Weero Co. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Apollo Duet (Model : APD-4000)?
The FDA product code for Apollo Duet (Model : APD-4000) is PBX.
相關臨床試驗
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相關器械（代碼：PBX）
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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