ESU-1 電外科電流發生器
K 號：K162656 · 2016-11-10
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器材摘要
ESU-1 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Tva Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K162656. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ESU-1 Electrosurgical Generator?
ESU-1 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Tva Medical, Inc.. The 510(k) number is K162656.
When did ESU-1 Electrosurgical Generator receive FDA 510(k) clearance?
ESU-1 Electrosurgical Generator received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162656.
Who is the listed applicant for ESU-1 Electrosurgical Generator?
The FDA 510(k) record lists Tva Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ESU-1 Electrosurgical Generator?
The FDA product code for ESU-1 Electrosurgical Generator is GEI.
相關臨床試驗
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相關器械（代碼：GEI）
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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