510(k) K002223

EPIC SPO2 FINGER SENSOR, MODEL E412-20 by Epic Medical Equipment Services, Inc. — Product Code DQA

K002223 is an FDA 510(k) premarket notification submitted by Epic Medical Equipment Services, Inc. for the device "EPIC SPO2 FINGER SENSOR, MODEL E412-20". The FDA issued a decision of Substantially Equivalent on August 22, 2000. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Epic Medical Equipment Services, Inc. has at least 10 other 510(k) clearances on record.