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FDA 510(k)

預設解決方案系統

K 號：K222635 · 2023-08-04

申請人Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
決定日期2023-08-04
產品代碼GKA
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

Premier Resolution System is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech (Primus Corporation, Dba Trinity Biotech). It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K222635. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Premier Resolution System?

Premier Resolution System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Trinity Biotech (Primus Corporation, Dba Trinity Biotech). The 510(k) number is K222635.

When did Premier Resolution System receive FDA 510(k) clearance?

Premier Resolution System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K222635.

Who is the listed applicant for Premier Resolution System?

The FDA 510(k) record lists Trinity Biotech (Primus Corporation, Dba Trinity Biotech) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premier Resolution System?

The FDA product code for Premier Resolution System is GKA.

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