拉西亞-三一
K 號：K241951 · 2024-10-10
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器材摘要
Lasya-Trinity is the device name listed in this FDA 510(k) record. The listed applicant is BLUECORE COMPANY Co., Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K241951. 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 Lasya-Trinity?
Lasya-Trinity is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is BLUECORE COMPANY Co., Ltd.. The 510(k) number is K241951.
When did Lasya-Trinity receive FDA 510(k) clearance?
Lasya-Trinity received FDA 510(k) clearance on 2024-10-10, under 510(k) number K241951.
Who is the listed applicant for Lasya-Trinity?
FDA 510(k) 記錄將 BLUECORE COMPANY Co., Ltd. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Lasya-Trinity?
The FDA product code for Lasya-Trinity is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 BLUECORE COMPANY Co., Ltd. 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：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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