VicorderCS (VCS-SYS-1100)
K 號：K260693 · 2026-06-16
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器材摘要
VicorderCS (VCS-SYS-1100) is the device name listed in this FDA 510(k) record. The listed applicant is 80 Beats Medical GmbH. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K260693. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VicorderCS (VCS-SYS-1100)?
VicorderCS (VCS-SYS-1100) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is 80 Beats Medical GmbH. The 510(k) number is K260693.
When did VicorderCS (VCS-SYS-1100) receive FDA 510(k) clearance?
VicorderCS (VCS-SYS-1100) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K260693.
Who is the listed applicant for VicorderCS (VCS-SYS-1100)?
The FDA 510(k) record lists 80 Beats Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VicorderCS (VCS-SYS-1100)?
The FDA product code for VicorderCS (VCS-SYS-1100) is DXN.
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相關器械（代碼：DXN）
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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