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510(k) Data Aggregation

    K Number
    K090296
    Device Name
    ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Date Cleared
    2009-02-19

    (13 days)

    Product Code
    KPT
    Regulation Number
    892.1360
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODEX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atomlab dose calibrators are used in Nuclear Medicine Departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients. The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.
    Device Description
    The Atomlab dose calibrator is comprised of a display unit and one or more connected argon gas filled pressurized jonization chamber detector unit. The calibration for the dose calibrator is contained in the chamber has a callbration certificate with it when it is shipped. Any of the Atomlab 400 and 500 displays can be connected to the chamber and will work correctly with the chamber since the calibration is stored in the chamber.
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    K Number
    K063666
    Device Name
    SHARPS CONTAINER, MODEL 039-413
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Date Cleared
    2007-01-25

    (45 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODEX MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Our Vertical Entry Sharps Container provides a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
    Device Description
    The Biodex Sharps Container consists of an injection molded polypropylene container fitted with an injection-molded snap on cover with a connected lid to the cover. The lid snaps onto the cover when the container is filled. The cover and lid are shipped not installed on the container bottom so the containers can be nested to save space. The cover is snapped onto the cover before use. The cover has an oval opening into which the Sharps are dropped vertically into the container.
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