510(k) K022453

MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM by Welch Allyn Protocol, Inc. — Product Code DSI

K022453 is an FDA 510(k) premarket notification submitted by Welch Allyn Protocol, Inc. for the device "MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 21, 2002. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Welch Allyn Protocol, Inc. has at least 6 other 510(k) clearances on record.