FDA 510(k)

EGPS導航儀器

K 號：K240160 · 2024-10-17

決定日期2024-10-17

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

EGPS Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K240160. 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 EGPS Navigated Instruments?

EGPS Navigated Instruments is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Astura Medical. The 510(k) number is K240160.

When did EGPS Navigated Instruments receive FDA 510(k) clearance?

EGPS Navigated Instruments received FDA 510(k) clearance on 2024-10-17, under 510(k) number K240160.

Who is the listed applicant for EGPS Navigated Instruments?

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

What is the FDA product code for EGPS Navigated Instruments?

The FDA product code for EGPS Navigated Instruments is OLO.

其他以 Astura Medical 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：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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