510(k) K063419

MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) by Welch Allyn Protocol, Inc. — Product Code MWI

K063419 is an FDA 510(k) premarket notification submitted by Welch Allyn Protocol, Inc. for the device "MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )". The FDA issued a decision of Substantially Equivalent on December 4, 2006. 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. Welch Allyn Protocol, Inc. has at least 6 other 510(k) clearances on record.