FDA 510(k)

VELO Respiratory Test

Número K: K251742 · 2026-02-13

Data da decisão2026-02-13

Código do produtoQOF

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VELO Respiratory Test is the device name listed in this FDA 510(k) record. The listed applicant is Lex Diagnostics Limited. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251742. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VELO Respiratory Test?

VELO Respiratory Test is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Lex Diagnostics Limited. The 510(k) number is K251742.

When did VELO Respiratory Test receive FDA 510(k) clearance?

VELO Respiratory Test received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251742.

Who is the listed applicant for VELO Respiratory Test?

The FDA 510(k) record lists Lex Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELO Respiratory Test?

The FDA product code for VELO Respiratory Test is QOF.

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