FDA 510(k)

Premier Resolution System

Número K: K222635 · 2023-08-04

RequerenteTrinity Biotech (Primus Corporation, Dba Trinity Biotech)

Data da decisão2023-08-04

Código do produtoGKA

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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