FDA 510(k)

Navigo Workstation 2.3 (FPRMC00039)

K 號：K250664 · 2025-08-07

決定日期2025-08-07

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Navigo Workstation 2.3 (FPRMC00039) is the device name listed in this FDA 510(k) record. The listed applicant is UC-CARE , Ltd.. It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K250664. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Navigo Workstation 2.3 (FPRMC00039)?

Navigo Workstation 2.3 (FPRMC00039) is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is UC-CARE , Ltd.. The 510(k) number is K250664.

When did Navigo Workstation 2.3 (FPRMC00039) receive FDA 510(k) clearance?

Navigo Workstation 2.3 (FPRMC00039) received FDA 510(k) clearance on 2025-08-07, under 510(k) number K250664.

Who is the listed applicant for Navigo Workstation 2.3 (FPRMC00039)?

FDA 510(k) 記錄將 UC-CARE, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Navigo Workstation 2.3 (FPRMC00039)?

The FDA product code for Navigo Workstation 2.3 (FPRMC00039) is LLZ.

其他以 UC-CARE , Ltd. 為申請人之記錄

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：LLZ）

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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