FDA 510(k)

Vital Signs Monitor (CLEO2)

Número K: K260438 · 2026-08-14

Data da decisão2026-08-14

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vital Signs Monitor (CLEO2) is the device name listed in this FDA 510(k) record. The listed applicant is Infinium Medical, Inc.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K260438. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vital Signs Monitor (CLEO2)?

Vital Signs Monitor (CLEO2) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Infinium Medical, Inc.. The 510(k) number is K260438.

When did Vital Signs Monitor (CLEO2) receive FDA 510(k) clearance?

Vital Signs Monitor (CLEO2) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K260438.

Who is the listed applicant for Vital Signs Monitor (CLEO2)?

The FDA 510(k) record lists Infinium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vital Signs Monitor (CLEO2)?

The FDA product code for Vital Signs Monitor (CLEO2) is MWI.

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