Ultimax-i, DREX-UI80 V1.60
K 號：K170832 · 2017-07-21
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器材摘要
Ultimax-i, DREX-UI80 V1.60 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K170832. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ultimax-i, DREX-UI80 V1.60?
Ultimax-i, DREX-UI80 V1.60 is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170832.
When did Ultimax-i, DREX-UI80 V1.60 receive FDA 510(k) clearance?
Ultimax-i, DREX-UI80 V1.60 received FDA 510(k) clearance on 2017-07-21, under 510(k) number K170832.
Who is the listed applicant for Ultimax-i, DREX-UI80 V1.60?
The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultimax-i, DREX-UI80 V1.60?
The FDA product code for Ultimax-i, DREX-UI80 V1.60 is OWB.
相關臨床試驗
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其他以 Toshibamedical Systems Corporation 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：OWB）
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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