510(k) K172312

eego amplifiers by Eemagine Medical Imaging Solutions GmbH — Product Code GWL

K172312 is an FDA 510(k) premarket notification submitted by Eemagine Medical Imaging Solutions GmbH for the device "eego amplifiers". The FDA issued a decision of Substantially Equivalent on March 30, 2018. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Eemagine Medical Imaging Solutions GmbH has at least 7 other 510(k) clearances on record.