510(k) K030297

FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 by Enraf-Nonius, B.V. — Product Code GXY

K030297 is an FDA 510(k) premarket notification submitted by Enraf-Nonius, B.V. for the device "FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130". The FDA issued a decision of Substantially Equivalent on April 28, 2003. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Enraf-Nonius, B.V. has at least 4 other 510(k) clearances on record.