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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
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MDILOG, MODEL MDC-512

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the MDILog, Model MDC-512, a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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