510(k) K240575

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) by Eemagine Medical Imaging Solutions GmbH — Product Code GXY

K240575 is an FDA 510(k) premarket notification submitted by Eemagine Medical Imaging Solutions GmbH for the device "WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)". The FDA issued a decision of Substantially Equivalent on November 25, 2024. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Eemagine Medical Imaging Solutions GmbH has at least 7 other 510(k) clearances on record.