510(k) K014269

POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 by Medtronic Functional Diagnostics A/S — Product Code MYE

K014269 is an FDA 510(k) premarket notification submitted by Medtronic Functional Diagnostics A/S for the device "POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102". The FDA issued a decision of Substantially Equivalent on November 21, 2002. The device falls under product code MYE (System, Electrogastrography (Egg)), a Class II device regulated under 21 CFR 876.1735. Medtronic Functional Diagnostics A/S has at least 10 other 510(k) clearances on record.