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510(k) Data Aggregation

    K Number
    K000220
    Device Name
    MA-300 ELECTROMYOGRAPHY SYSTEM
    Date Cleared
    2000-02-24

    (31 days)

    Product Code
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOTION LAB SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K974385
    Device Name
    MLS ELECTROMYOGRAPHIC PREAMPLIFIER
    Date Cleared
    1998-02-19

    (90 days)

    Product Code
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOTION LAB SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MLS Electromyographic preamplifier enables researchers and clinicians to acquire EMG signals from active subjects. It is intended to be used in hospital, university and other research facilities to acquire EMG signals for display and analysis by, or under the direction of, a health care professional.
    Device Description
    The purpose of the MLS Electromyographic preamplifier is to amplify the myoelectric signals that are generated by muscles when they contract.
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