FDA 510(k)

Delphi Stimulator

N.º K: K242345 · 2024-11-05

Fecha de decisión2024-11-05

Código de productoGWF

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Delphi Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neuroscience. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K242345. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Delphi Stimulator?

Delphi Stimulator is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Quantalx Neuroscience. The 510(k) number is K242345.

When did Delphi Stimulator receive FDA 510(k) clearance?

Delphi Stimulator received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242345.

Who is the listed applicant for Delphi Stimulator?

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

What is the FDA product code for Delphi Stimulator?

The FDA product code for Delphi Stimulator is GWF.

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Fuente oficial

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