510(k) K022677

MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE by Alaris Medical Systems, Inc. — Product Code DQA

K022677 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE". The FDA issued a decision of Substantially Equivalent on September 11, 2002. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.