FDA 510(k)

NavLock 跟蹤器，機械參考框架

K 號：K182104 · 2018-11-02

決定日期2018-11-02

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

NavLock Trackers, Robotic Reference Frame is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182104. 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 NavLock Trackers, Robotic Reference Frame?

NavLock Trackers, Robotic Reference Frame is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Medtronic Navigation. The 510(k) number is K182104.

When did NavLock Trackers, Robotic Reference Frame receive FDA 510(k) clearance?

NavLock Trackers, Robotic Reference Frame received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182104.

Who is the listed applicant for NavLock Trackers, Robotic Reference Frame?

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

What is the FDA product code for NavLock Trackers, Robotic Reference Frame?

The FDA product code for NavLock Trackers, Robotic Reference Frame is OLO.

其他以 Medtronic Navigation 為申請人之記錄

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