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510(k) K011472

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID by Medtronic Functional Diagnostics A/S — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2001
Date Received
May 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Medtronic Functional Diagnostics A/S

  • K014269 — POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF (November 21, 2002)
  • K011471 — BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PRO (November 8, 2002)
  • K002992 — DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013 (August 15, 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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