FDA 510(k)

育空OCT脊椎系統

K 號：K193129 · 2020-02-07

決定日期2020-02-07

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Yukon OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K193129. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Yukon OCT Spinal System?

Yukon OCT Spinal System is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is K2m, Inc.. The 510(k) number is K193129.

When did Yukon OCT Spinal System receive FDA 510(k) clearance?

Yukon OCT Spinal System received FDA 510(k) clearance on 2020-02-07, under 510(k) number K193129.

Who is the listed applicant for Yukon OCT Spinal System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yukon OCT Spinal System?

The FDA product code for Yukon OCT Spinal System is NKG.

其他以 K2m, Inc. 為申請人之記錄

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相關器械（代碼：NKG）

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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