510(k) K120774

ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT by Welch Allyn, Inc. — Product Code DSI

K120774 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT". The FDA issued a decision of Substantially Equivalent on April 10, 2012. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.