FDA 510(k)

脊椎導航與機械輔助設備

K 號：K233228 · 2024-06-14

決定日期2024-06-14

產品代碼OLO

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

Spine Navigation and Robotic-Assistance Device is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K233228. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spine Navigation and Robotic-Assistance Device?

Spine Navigation and Robotic-Assistance Device is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Ecential Robotics. The 510(k) number is K233228.

When did Spine Navigation and Robotic-Assistance Device receive FDA 510(k) clearance?

Spine Navigation and Robotic-Assistance Device received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233228.

Who is the listed applicant for Spine Navigation and Robotic-Assistance Device?

FDA 510(k) 記錄將 Ecential Robotics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Spine Navigation and Robotic-Assistance Device?

The FDA product code for Spine Navigation and Robotic-Assistance Device is OLO.

其他以 Ecential Robotics 為申請人之記錄

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相關器械（代碼：OLO）

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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