FDA 510(k)

Anura Mobile Core SDK (M1)

Número K: K253650 · 2026-06-11

Data da decisão2026-06-11

Código do produtoQME

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anura Mobile Core SDK (M1) is the device name listed in this FDA 510(k) record. The listed applicant is Nuralogix Corporation. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253650. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anura Mobile Core SDK (M1)?

Anura Mobile Core SDK (M1) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Nuralogix Corporation. The 510(k) number is K253650.

When did Anura Mobile Core SDK (M1) receive FDA 510(k) clearance?

Anura Mobile Core SDK (M1) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253650.

Who is the listed applicant for Anura Mobile Core SDK (M1)?

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

What is the FDA product code for Anura Mobile Core SDK (M1)?

The FDA product code for Anura Mobile Core SDK (M1) is QME.

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