FDA 510(k)

MyOnyx系統

K 號：K201014 · 2021-01-13

決定日期2021-01-13

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

MyOnyx System is the device name listed in this FDA 510(k) record. The listed applicant is Thought Technology , Ltd.. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K201014. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MyOnyx System?

MyOnyx System is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Thought Technology , Ltd.. The 510(k) number is K201014.

When did MyOnyx System receive FDA 510(k) clearance?

MyOnyx System received FDA 510(k) clearance on 2021-01-13, under 510(k) number K201014.

Who is the listed applicant for MyOnyx System?

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

What is the FDA product code for MyOnyx System?

The FDA product code for MyOnyx System is KPI.

其他以 Thought Technology , Ltd. 為申請人之記錄

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K213197MyOnyx系統

相關器械（代碼：KPI）

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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