FDA 510(k)

CORUS導航存取系統

K 號：K240625 · 2024-05-03

決定日期2024-05-03

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

CORUS Navigation Access System is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K240625. 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 CORUS Navigation Access System?

CORUS Navigation Access System is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K240625.

When did CORUS Navigation Access System receive FDA 510(k) clearance?

CORUS Navigation Access System received FDA 510(k) clearance on 2024-05-03, under 510(k) number K240625.

Who is the listed applicant for CORUS Navigation Access System?

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

What is the FDA product code for CORUS Navigation Access System?

The FDA product code for CORUS Navigation Access System is OLO.

其他以 Providence Medical Technology, Inc. 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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