SOZO Pro
K 號:K232089 · 2023-10-17
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器材摘要
SOZO Pro is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K232089. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SOZO Pro?
SOZO Pro is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is ImpediMed Limited. The 510(k) number is K232089.
When did SOZO Pro receive FDA 510(k) clearance?
SOZO Pro received FDA 510(k) clearance on 2023-10-17, under 510(k) number K232089.
Who is the listed applicant for SOZO Pro?
FDA 510(k) 記錄將 ImpediMed Limited 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for SOZO Pro?
The FDA product code for SOZO Pro is DSB.
其他以 ImpediMed Limited 為申請人之記錄
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相關器械(代碼:DSB)
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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