GSI Audera Pro
K 號：K193033 · 2020-04-24
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器材摘要
GSI Audera Pro is the device name listed in this FDA 510(k) record. The listed applicant is Grason Stadler. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K193033. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GSI Audera Pro?
GSI Audera Pro is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Grason Stadler. The 510(k) number is K193033.
When did GSI Audera Pro receive FDA 510(k) clearance?
GSI Audera Pro received FDA 510(k) clearance on 2020-04-24, under 510(k) number K193033.
Who is the listed applicant for GSI Audera Pro?
The FDA 510(k) record lists Grason Stadler as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GSI Audera Pro?
The FDA product code for GSI Audera Pro is GWJ.
相關臨床試驗
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相關器械（代碼：GWJ）
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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