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

    DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD

    K Number: K896476 · Decision Jan 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    47
    Applicant Total
    49
    Review Days
    70

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    Basic Information

    Device Name
    DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
    K Number
    K896476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1390
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Medipart Jerry Alexander
    Date Received
    November 13, 1989
    Decision Date
    January 22, 1990
    Product Code
    IYT
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYT System, Rebreathing, Radionuclide

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