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510(k) Data Aggregation

    K Number
    K980866
    Device Name
    MEDI-DX 7000 CPT WITH AMREX ELECTRODES
    Manufacturer
    NEURO-DIAGNOSTIC ASSOC.
    Date Cleared
    1998-05-20

    (90 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO-DIAGNOSTIC ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological imparments. The population of subjects for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The Medi-Dx 7000 diagnostic examination may be conducted as part of a routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.
    Device Description
    Approved 12/01/97, the Medi-Dx 7000 is a Current Perception Threshold (CPT) device for the examination of peripheral neuropathies. It generates sinusoidal electrical currents in the 5 Hz, 250 Hz and 2000 Hz frequencies from 0 mA to 9.99 mA. The Medi-Dx 7000 weighs approximately 15 Ibs. and is housed within a 12" x 5" x 11" heavy duty plastic case with metal face and rear panels. The rear panel has an access door for installation and replacement of (8) standard (6) Volt Alkaline Batteries. The Face panel has an 'ON/OFF' switch, a 'Battery Test' switch (also functioning as an automatic calibration switch), and three (3) switches, one for each of the frequencies; 5 Hz, 250 Hz and 2000 Hz respectively. The intensity control is immediately below an LCD which reads mA output. Two ports are available on the from panel for connection with electrodes.
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    K Number
    K964622
    Device Name
    MEDI-DX 7000
    Manufacturer
    NEURO-DIAGNOSTIC ASSOC.
    Date Cleared
    1997-12-01

    (378 days)

    Product Code
    LLN
    Regulation Number
    882.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO-DIAGNOSTIC ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The Medi-Dx 7000 diagnostic examination may be conducted as part of a routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.
    Device Description
    The Medi-Dx 7000 is a Current Perception Threshold (CPT) device for the examination of peripheral neuropathies. It generates a sinusoidal electrical currents in the 5 Hz, 250 Hz and 2000 Hz frequencies from 0 mA to 9.99 mA. The Medi-Dx 7000 weighs approximately 15 lbs. and is housed within a 12" x 6" x 11" heavy duty plastic case with metal face and rear panels. The rear panel has an access door for installation and replacement of (8) standard (6) Volt Alkaline Batteries. The Face panel has an 'ON/OFF' switch, a 'Battery Test' switch (also functioning as an automatic calibration switch), and three (3) switches, one for each of the frequencies; 5 Hz, 250 Hz and 2000 Hz respectively. The intensity control is immediately below an LCD which reads mA output. Two ports are available on the from panel for connection with electrodes (which are not provided with the unit and are ordered by the user from suppliers mentioned in the owners manual).
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