FDA 510(k)

OneStim-DUO Cardiac Stimulator (MP5003-4CO)

Número K: K253088 · 2026-06-12

Data da decisão2026-06-12

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

OneStim-DUO Cardiac Stimulator (MP5003-4CO) is the device name listed in this FDA 510(k) record. The listed applicant is Micropace Pty, Ltd.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K253088. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

OneStim-DUO Cardiac Stimulator (MP5003-4CO) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Micropace Pty, Ltd.. The 510(k) number is K253088.

When did OneStim-DUO Cardiac Stimulator (MP5003-4CO) receive FDA 510(k) clearance?

OneStim-DUO Cardiac Stimulator (MP5003-4CO) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253088.

Who is the listed applicant for OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

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

What is the FDA product code for OneStim-DUO Cardiac Stimulator (MP5003-4CO)?

The FDA product code for OneStim-DUO Cardiac Stimulator (MP5003-4CO) is DQK.

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Fonte oficial

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