艾力克塔合一
K 號：K192482 · 2019-12-05
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器材摘要
Elekta Unity is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Limited. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K192482. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Elekta Unity?
Elekta Unity is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Elekta Limited. The 510(k) number is K192482.
When did Elekta Unity receive FDA 510(k) clearance?
Elekta Unity received FDA 510(k) clearance on 2019-12-05, under 510(k) number K192482.
Who is the listed applicant for Elekta Unity?
The FDA 510(k) record lists Elekta Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elekta Unity?
The FDA product code for Elekta Unity is IYE.
相關臨床試驗
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其他以 Elekta 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：IYE）
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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