FDA 510(k)

Definium Pace Select ET

Número K: K242678 · 2024-10-01

RequerenteGe Hualun Medical Systems Co. , Ltd.

Data da decisão2024-10-01

Código do produtoKPR

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Definium Pace Select ET is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K242678. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Definium Pace Select ET?

Definium Pace Select ET is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K242678.

When did Definium Pace Select ET receive FDA 510(k) clearance?

Definium Pace Select ET received FDA 510(k) clearance on 2024-10-01, under 510(k) number K242678.

Who is the listed applicant for Definium Pace Select ET?

The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Definium Pace Select ET?

The FDA product code for Definium Pace Select ET is KPR.

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Fonte oficial

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