DUET-V（型號：ESK-3261DV）
K 號：K233118 · 2025-01-03
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器材摘要
DUET-V (Model: ESK-3261DV) is the device name listed in this FDA 510(k) record. The listed applicant is Eunsung Global Corp. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K233118. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DUET-V (Model: ESK-3261DV)?
DUET-V (Model: ESK-3261DV) is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Eunsung Global Corp. The 510(k) number is K233118.
When did DUET-V (Model: ESK-3261DV) receive FDA 510(k) clearance?
DUET-V (Model: ESK-3261DV) received FDA 510(k) clearance on 2025-01-03, under 510(k) number K233118.
Who is the listed applicant for DUET-V (Model: ESK-3261DV)?
The FDA 510(k) record lists Eunsung Global Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DUET-V (Model: ESK-3261DV)?
The FDA product code for DUET-V (Model: ESK-3261DV) is GEI.
相關臨床試驗
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：GEI）
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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