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FDA 510(k)

SOZO

K 號：K180126 · 2018-04-16

申請人ImpediMed Limited
決定日期2018-04-16
產品代碼OBH
諮詢委員會履歷
決定相當於

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 2018-04-16 under 510(k) number K180126. The device is classified under product code OBH. 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 2018-04-16. The listed applicant is ImpediMed Limited. The 510(k) number is K180126.

When did SOZO receive FDA 510(k) clearance?

SOZO received FDA 510(k) clearance on 2018-04-16, under 510(k) number K180126.

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 OBH.

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。

K260224MySOZO軟體版本6.1.0.1（軟體版本6.1.0.1）K253224MySOZO軟體版本6.0.1.2（軟體版本6.0.1.2）K232089SOZO ProK230530SOZO ProK230531SOZO ProK203473SOZO

查看所有 11 項裝置 →

相關器械（代碼：OBH）

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。

K253224MySOZO軟體版本6.0.1.2（軟體版本6.0.1.2）ImpediMed LimitedK230530SOZO ProImpediMed LimitedK220557MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd.K172122SOZOImpediMed Limited

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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