510(k) K010130

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 by Medtronic Functional Diagnostics A/S — Product Code FFX

K010130 is an FDA 510(k) premarket notification submitted by Medtronic Functional Diagnostics A/S for the device "POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103". The FDA issued a decision of Substantially Equivalent on February 7, 2001. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medtronic Functional Diagnostics A/S has at least 10 other 510(k) clearances on record.