FDA 510(k)

個人動態圖像系統（PKG）第二代 Plus

K 號：K211887 · 2022-03-11

決定日期2022-03-11

產品代碼GYD

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

Personal Kinetigraph (PKG) System Gen 2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Gkc Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K211887. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Personal Kinetigraph (PKG) System Gen 2 Plus?

Personal Kinetigraph (PKG) System Gen 2 Plus is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Gkc Manufacturing Pty, Ltd.. The 510(k) number is K211887.

When did Personal Kinetigraph (PKG) System Gen 2 Plus receive FDA 510(k) clearance?

Personal Kinetigraph (PKG) System Gen 2 Plus received FDA 510(k) clearance on 2022-03-11, under 510(k) number K211887.

Who is the listed applicant for Personal Kinetigraph (PKG) System Gen 2 Plus?

The FDA 510(k) record lists Gkc Manufacturing Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Personal Kinetigraph (PKG) System Gen 2 Plus?

The FDA product code for Personal Kinetigraph (PKG) System Gen 2 Plus is GYD.

其他以 Gkc Manufacturing Pty, Ltd. 為申請人之記錄

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K161717個人動態圖記系統 (PKG)

相關器械（代碼：GYD）

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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