SANDRO Dual
K 號：K252877 · 2025-12-19
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器材摘要
SANDRO Dual is the device name listed in this FDA 510(k) record. The listed applicant is Wontech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252877. 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 SANDRO Dual?
SANDRO Dual is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Wontech Co., Ltd.. The 510(k) number is K252877.
When did SANDRO Dual receive FDA 510(k) clearance?
SANDRO Dual received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252877.
Who is the listed applicant for SANDRO Dual?
The FDA 510(k) record lists Wontech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SANDRO Dual?
The FDA product code for SANDRO Dual is GEX. This falls under the Gastroenterology category.
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其他以 Wontech Co., Ltd. 為申請人之記錄
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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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