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Medtronic Functional Diagnostics A/S

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K014269 POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102MYE2002-11-21 View
510(k) K011471 BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBERFFX2002-11-08 View
510(k) K002992 DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431IKT2001-08-15 View
510(k) K011472 POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF IDFFX2001-08-10 View
510(k) K010130 POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103FFX2001-02-07 View
510(k) K000386 POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111FFX2000-05-05 View
510(k) K992715 NEURO URODYNAMIC SUITE, MODEL 9032E0101FEN2000-02-28 View
510(k) K992713 POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101FFX1999-11-10 View
510(k) K991389 ANORECTAL MANOMETRY SUITE, MODEL 9032S0201FFX1999-07-15 View
510(k) K990375 DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKT1999-03-09 View
510(k) K981733 DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111FFX1999-02-04 View
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