FDA 510(k)

Origin™

Número K: K243965 · 2025-08-21

RequerenteNerv Technology Inc. (D.B.A.) Fluidai Medical

Data da decisão2025-08-21

Código do produtoSFO

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Origin™ is the device name listed in this FDA 510(k) record. The listed applicant is Nerv Technology Inc. (D.B.A.) Fluidai Medical. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K243965. The device is classified under product code SFO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Origin™?

Origin™ is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Nerv Technology Inc. (D.B.A.) Fluidai Medical. The 510(k) number is K243965.

When did Origin™ receive FDA 510(k) clearance?

Origin™ received FDA 510(k) clearance on 2025-08-21, under 510(k) number K243965.

Who is the listed applicant for Origin™?

The FDA 510(k) record lists Nerv Technology Inc. (D.B.A.) Fluidai Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Origin™?

The FDA product code for Origin™ is SFO.

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