510(k) K211147

ALGO 7i by Path Medical GmbH — Product Code GWJ

K211147 is an FDA 510(k) premarket notification submitted by Path Medical GmbH for the device "ALGO 7i". The FDA issued a decision of Substantially Equivalent on October 14, 2021. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Path Medical GmbH has at least 5 other 510(k) clearances on record.