510(k) K242345

Delphi Stimulator by Quantalx Neuroscience — Product Code GWF

K242345 is an FDA 510(k) premarket notification submitted by Quantalx Neuroscience for the device "Delphi Stimulator". The FDA issued a decision of Substantially Equivalent on November 5, 2024. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Quantalx Neuroscience has at least 2 other 510(k) clearances on record.