FDA 510(k)

VisuBreath

Número K: K261633 · 2026-07-14

RequerenteAffirm Medical Technologies II, LLC

Data da decisão2026-07-14

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

VisuBreath is the device name listed in this FDA 510(k) record. The listed applicant is Affirm Medical Technologies II, LLC. It received FDA 510(k) clearance on 2026-07-14 under 510(k) number K261633. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VisuBreath?

VisuBreath is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Affirm Medical Technologies II, LLC. The 510(k) number is K261633.

When did VisuBreath receive FDA 510(k) clearance?

VisuBreath received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261633.

Who is the listed applicant for VisuBreath?

The FDA 510(k) record lists Affirm Medical Technologies II, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisuBreath?

The FDA product code for VisuBreath is CCK.

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