510(k) K992713

POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 by Medtronic Functional Diagnostics A/S — Product Code FFX

K992713 is an FDA 510(k) premarket notification submitted by Medtronic Functional Diagnostics A/S for the device "POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101". The FDA issued a decision of Substantially Equivalent on November 10, 1999. 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.