FDA 510(k)

LARS ACJ

Número K: K253115 · 2026-06-10

Data da decisão2026-06-10

Código do produtoHTN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LARS ACJ is the device name listed in this FDA 510(k) record. The listed applicant is Movmedix S.A.S.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K253115. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LARS ACJ?

LARS ACJ is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Movmedix S.A.S.. The 510(k) number is K253115.

When did LARS ACJ receive FDA 510(k) clearance?

LARS ACJ received FDA 510(k) clearance on 2026-06-10, under 510(k) number K253115.

Who is the listed applicant for LARS ACJ?

The FDA 510(k) record lists Movmedix S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LARS ACJ?

The FDA product code for LARS ACJ is HTN.

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Fonte oficial

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