Stardust醫療設備規範文本
K 號：K200736 · 2020-06-26
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器材摘要
Stardust Med is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. Group S.R.L.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200736. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Stardust Med?
Stardust Med is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is I.T.S. Group S.R.L.. The 510(k) number is K200736.
When did Stardust Med receive FDA 510(k) clearance?
Stardust Med received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200736.
Who is the listed applicant for Stardust Med?
The FDA 510(k) record lists I.T.S. Group S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stardust Med?
The FDA product code for Stardust Med is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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相關器械（代碼：GEX）
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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