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510(k) Data Aggregation

    K Number
    K141872
    Device Name
    SUDOSCAN
    Manufacturer
    IMPETO MEDICAL INC
    Date Cleared
    2014-11-21

    (133 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPETO MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function. SUDOSCAN is indicated for use in the general adult population.
    Device Description
    SUDOSCAN is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN devices use both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements. The SUDOSCAN system is composed of: - analog acquisition electronic circuitry with low-noise front end - multiplexing control unit for selecting the appropriate acquisition channels - optically isolated USB interface controller - power converter - 4 electrodes placed on the feet and the hands - touch-screen computer running the proprietary SUDOSCAN software
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    K Number
    K100233
    Device Name
    SUDOSCAN
    Manufacturer
    IMPETO MEDICAL
    Date Cleared
    2010-06-14

    (139 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPETO MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SudoScan system is a medical device for the measurement of galvanic skin responses.
    Device Description
    SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements. SUDOSCAN device is composed of: - -> The analog acquisition electronic circuitry with low-noise front end - → The multiplexing control unit for selecting the appropriate acquisition channels - -> The signal formatting and processing capabilities - > The optically isolated USB interface controller - -> The power converter, - > The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.
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