510(k) K233354

WVSM Pro (Series) (500-0030-XX) by Athena Gtx, Inc. — Product Code MWI

K233354 is an FDA 510(k) premarket notification submitted by Athena Gtx, Inc. for the device "WVSM Pro (Series) (500-0030-XX)". The FDA issued a decision of Substantially Equivalent on June 26, 2024. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Athena Gtx, Inc. has at least 7 other 510(k) clearances on record.