FDA 510(k)

DistaSense(TM) (v1)

Número K: K254058 · 2026-09-25

Data da decisão2026-09-25

Código do produtoDRT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DistaSense(TM) (v1) is the device name listed in this FDA 510(k) record. The listed applicant is Life Detection Technologies. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254058. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

O que é o DistaSense(TM) (v1)?

DistaSense(TM) (v1) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Life Detection Technologies. The 510(k) number is K254058.

When did DistaSense(TM) (v1) receive FDA 510(k) clearance?

DistaSense(TM) (v1) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254058.

Who is the listed applicant for DistaSense(TM) (v1)?

The FDA 510(k) record lists Life Detection Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DistaSense(TM) (v1)?

The FDA product code for DistaSense(TM) (v1) is DRT.

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