The Botticelli（型號：Athena）
K 號：K251699 · 2025-10-08
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器材摘要
The Botticelli (Model: Athena) is the device name listed in this FDA 510(k) record. The listed applicant is Bellamia Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K251699. 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 The Botticelli (Model: Athena)?
The Botticelli (Model: Athena) is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Bellamia Technologies, Inc.. The 510(k) number is K251699.
When did The Botticelli (Model: Athena) receive FDA 510(k) clearance?
The Botticelli (Model: Athena) received FDA 510(k) clearance on 2025-10-08, under 510(k) number K251699.
Who is the listed applicant for The Botticelli (Model: Athena)?
The FDA 510(k) record lists Bellamia Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for The Botticelli (Model: Athena)?
The FDA product code for The Botticelli (Model: Athena) 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
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