510(k) K082256

LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE by Integrated Medical Systems, Inc. — Product Code MWI

K082256 is an FDA 510(k) premarket notification submitted by Integrated Medical Systems, Inc. for the device "LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE". The FDA issued a decision of Substantially Equivalent on September 26, 2008. 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. Integrated Medical Systems, Inc. has at least 4 other 510(k) clearances on record.