SOZO
K 號：K172507 · 2017-12-22
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器材摘要
SOZO is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K172507. 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?
SOZO is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is ImpediMed Limited. The 510(k) number is K172507.
When did SOZO receive FDA 510(k) clearance?
SOZO received FDA 510(k) clearance on 2017-12-22, under 510(k) number K172507.
Who is the listed applicant for SOZO?
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?
The FDA product code for SOZO is DSB.
其他以 ImpediMed Limited 為申請人之記錄
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：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。
K260224MySOZO軟體版本6.1.0.1（軟體版本6.1.0.1）ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727關於Balans醫療設備規範文本
Re:BalansMode Sensors ASK250922腫脹守護監測器（EGM） cardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex監控系統，型號CM-1600Zynex Medical, Inc.
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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