510(k) K041522

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS by Elekon Industries U.S.A., Inc. — Product Code DQA

K041522 is an FDA 510(k) premarket notification submitted by Elekon Industries U.S.A., Inc. for the device "FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS". The FDA issued a decision of Substantially Equivalent on September 14, 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.