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FDA 510(k)

UB ERP系統

K 號：K253767 · 2026-06-30

申請人Universal Brain
決定日期2026-06-30
產品代碼OLT
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

UB ERP System is the device name listed in this FDA 510(k) record. The listed applicant is Universal Brain. It received FDA 510(k) clearance on 2026-06-30 under 510(k) number K253767. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UB ERP System?

UB ERP System is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Universal Brain. The 510(k) number is K253767.

When did UB ERP System receive FDA 510(k) clearance?

UB ERP System received FDA 510(k) clearance on 2026-06-30, under 510(k) number K253767.

Who is the listed applicant for UB ERP System?

The FDA 510(k) record lists Universal Brain as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UB ERP System?

The FDA product code for UB ERP System is OLT.

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。

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相關器械（代碼：OLT）

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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