Gastro Concepts 氣動輔助設備
K 號：K242668 · 2024-12-13
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器材摘要
Gastro Concepts Air Assist is the device name listed in this FDA 510(k) record. The listed applicant is Gastro Concepts, LLC. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K242668. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Gastro Concepts Air Assist?
Gastro Concepts Air Assist is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Gastro Concepts, LLC. The 510(k) number is K242668.
When did Gastro Concepts Air Assist receive FDA 510(k) clearance?
Gastro Concepts Air Assist received FDA 510(k) clearance on 2024-12-13, under 510(k) number K242668.
Who is the listed applicant for Gastro Concepts Air Assist?
The FDA 510(k) record lists Gastro Concepts, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gastro Concepts Air Assist?
The FDA product code for Gastro Concepts Air Assist is FER.
相關臨床試驗
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相關器械（代碼：FER）
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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