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510(k) Data Aggregation

    K Number
    K014269
    Device Name
    POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2002-11-21

    (329 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
    Device Description
    The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.
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    K Number
    K011471
    Device Name
    BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2002-11-08

    (543 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
    Device Description
    The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.
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    K Number
    K002992
    Device Name
    DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2001-08-15

    (324 days)

    Product Code
    IKT, FMI, GXZ
    Regulation Number
    890.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011472
    Device Name
    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2001-08-10

    (88 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010130
    Device Name
    POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2001-02-07

    (22 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000386
    Device Name
    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2000-05-05

    (88 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992715
    Device Name
    NEURO URODYNAMIC SUITE, MODEL 9032E0101
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2000-02-28

    (200 days)

    Product Code
    FEN, GWF, JXE
    Regulation Number
    876.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuro-Urodynamics Suite for Duet / Duet MultiP is indicated for electrophysiological testing of the pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
    Device Description
    The Duet version 8.1 is enhanced with a new suite of test programs for EMG and Motor Nerve conduction measurements. The suite is called Neuro Urodynamics Suite and consists of the following predefined testprogram: - Neuro Free Run EMG - Neuro Motor Nerve Conduction - Neuro Sacral Reflex The Neuro Urodynamic Suite is together with Duet MultiP intended to record a patients urodynamic functions and examination of the motor innervation of the spincters and the pelvic floor and the sensory innervation of pelvic structures. The whole system includes transducers, devices, tubing, catheters and electrodes. The tests are operated just like the urodynamic and anorectal tests. A license number is required to enable the software for the Neuro Urodynamic Suite.
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    K Number
    K992713
    Device Name
    POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    1999-11-10

    (90 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
    Device Description
    The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
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    K Number
    K991389
    Device Name
    ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    1999-07-15

    (85 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Duet-with Anorectal Manometry Suite is intended to measure and record the functioning of the patient's urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes. * expanded indication for use due to the Anorectal Manometry Suite.
    Device Description
    The Anorectal Manometry Suit is together with Duet/Duet MultiP intended to record a patients anorectal function compromising EMG and pressure recordings. The whole system includes transducers, devices, tubing, catheters and electrodes. The Duet / Duet MultiP is an apparatus capable of registration of pressure signals over a long time. The measurements and analysis have originally been developed for urodynamics tests, but since anorectal tests also are measuring pressure signals over a period of time, it is suitable to use the same technique for these types of tests, i.e. anorectal tests. The device is used in a dedicated clinical setup. The following sets of test types are predefined tests for measuring in the rectum: Sphincter Profile, Resting Pressure, Rectal Balloon test, Balloon Expulsion Test, Squeeze Test, Recto-Anal Inhibitory Test. The tests are operated just like the urodynamic tests. A license number is required to enable the software for the Anorectal Manometry Suite.
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    K Number
    K990375
    Device Name
    DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    1999-03-09

    (29 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies. This process is known as electromyography (EMG).
    Device Description
    The disposable monopolar needle electrode is designed for single use only. The stainless steel needle electrode is insulated with a special PTFE coating to ensure minimal friction between the needle and the tissue. The tip of the conically sharpened needle is uninsulated and serves as recording area. The sterile electrode is individually sealed and delivered in sets of 48 pcs. In a hygienic and practical package ready for use package. The electrodes consists of a PTFE coated needle with an exposed area in the tip. The PTFE coating eases insertion into tissue and isolates the needle electrical. There are two diameters of the needles. In the non-invasive end of the device there is attached a connector, which enables the electrical signal to be transferred to the cable.
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