510(k) K101674

WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 by Athena Gtx — Product Code MWI

K101674 is an FDA 510(k) premarket notification submitted by Athena Gtx for the device "WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0". The FDA issued a decision of Substantially Equivalent on July 21, 2010. 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 has at least 7 other 510(k) clearances on record.