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510(k) Data Aggregation

    K Number
    K990185
    Device Name
    MDILOG, MODEL MDC-512
    Manufacturer
    MEDTRAK TECHNOLOGIES, INC.
    Date Cleared
    1999-04-01

    (71 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRAK TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed he any The MDILog is intended for use by a single patient under the care of themient of a pirposition of the MDLog can be used by any THC MDIEog is preseribed by as prescribed by a physician. It will be the physician or health care professionality to contact and coordinate with Medirac Technologies to acquire It will be the physician of health care protessonal s responsibility of tonactions. MDIs with attached MDILog and attach the MDILog Titel adapter, sice v adapter bodies and hiscian or health care professional.
    Device Description
    MDILog, model MDC-512
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    K Number
    K970344
    Device Name
    MDILOG, MODEL MDC-511
    Manufacturer
    MEDTRAK TECHNOLOGIES, INC.
    Date Cleared
    1997-08-06

    (189 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRAK TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (MDIs) and allows for the physician to assess patients' techniques in using MDIs. The MDILog is intended for outpatient use by a single individual under the care or treatment of a physician or licensed health care professional. The device is to be used whenever patient compliance monitoring is indicated. The health care professional prescribes the patient medication treatment plan and MDILog monitors and records MDI medication usage. The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed health care professional. The MDILog is prescribed by the doctor when MDI usage monitoring is indicated. The MDILog can be used by any patient who regularly uses MDIs as prescribed by a physician.
    Device Description
    The MDILog system monitors the compliance of asthma and chronic respiratory patients with metered dose inhalers (MDIs) and allows the physician to assesses patients' technique in using MDIs. The system consists of the MDLog electronic monitor, an adapter, a docking station to communicate to an IBM compatible personal computer, and software. The MDILog monitor is a small electronics module operating on a 3-volt battery that attaches to the dispensing boot of a metered dose inhaler (MDI). It records the time and date when a patient uses an MDI, measures certain properties of the patient's technique, and transmits these data to a docking station, which transmits the data to a computer. Attached onto outside of dispenser body. Heated thermister used to detect air flow, mechanical beam with strain gage used to detect canister actuation and moving magnet used to detect shake. Data stored in device memory for later retrieval.
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