510(k) K042704

REUSABLE FINGER CLIP SPO2 SENSORS by Elekon Industries U.S.A., Inc. — Product Code DQA

K042704 is an FDA 510(k) premarket notification submitted by Elekon Industries U.S.A., Inc. for the device "REUSABLE FINGER CLIP SPO2 SENSORS". The FDA issued a decision of Substantially Equivalent on November 26, 2004. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Elekon Industries U.S.A., Inc. has at least 5 other 510(k) clearances on record.