510(k) K992211

SPO2 WRAP SENSOR by Epic Medical Equipment Services, Inc. — Product Code DQA

K992211 is an FDA 510(k) premarket notification submitted by Epic Medical Equipment Services, Inc. for the device "SPO2 WRAP SENSOR". The FDA issued a decision of Substantially Equivalent on December 22, 1999. 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.