ISEN-Goggles 配合資料檢視器
K 號：K163270 · 2017-09-25
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器材摘要
ISEN-Goggles with Data Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Isent Tech & Trading Company, Ltd.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K163270. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ISEN-Goggles with Data Viewer?
ISEN-Goggles with Data Viewer is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Isent Tech & Trading Company, Ltd.. The 510(k) number is K163270.
When did ISEN-Goggles with Data Viewer receive FDA 510(k) clearance?
ISEN-Goggles with Data Viewer received FDA 510(k) clearance on 2017-09-25, under 510(k) number K163270.
Who is the listed applicant for ISEN-Goggles with Data Viewer?
The FDA 510(k) record lists Isent Tech & Trading Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ISEN-Goggles with Data Viewer?
The FDA product code for ISEN-Goggles with Data Viewer is GWN.
相關臨床試驗
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：GWN）
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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