BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

    K Number: K090296 · Decision Feb 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    9
    Review Days
    13

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    Basic Information

    Device Name
    ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
    K Number
    K090296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1360
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biodex Medical Systems, Inc.
    Date Received
    February 6, 2009
    Decision Date
    February 19, 2009
    Product Code
    KPT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPT Calibrator, Dose, Radionuclide

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