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510(k) K014269

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 21, 2002
Date Received: December 27, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Electrogastrography (Egg)
Device Class: Class II
Regulation Number: 876.1735
Review Panel: GU
Submission Type

Other clearances by Medtronic Functional Diagnostics A/S

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K002992 — DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013 (August 15, 2001)
K011472 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOM (August 10, 2001)
K010130 — POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 (February 7, 2001)
K000386 — POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 (May 5, 2000)
K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
K992713 — POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G (November 10, 1999)
K991389 — ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (July 15, 1999)
K990375 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; D (March 9, 1999)
K981733 — DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (February 4, 1999)

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K223398 — Gastric Alimetry System (April 27, 2023)
K213924 — Gastric Alimetry System (June 3, 2022)
K212954 — G-Tech Wireless Patch System (WPS) (January 10, 2022)
DEN990005 — THE 3PM EGG MACHINE (August 20, 1999)