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

    COLD/HOT FLUID RADIATION PAD NEUTECH

    K Number: K893706 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    92
    Applicant Total
    7
    Review Days
    35

    Basic Information

    Device Name
    COLD/HOT FLUID RADIATION PAD NEUTECH
    K Number
    K893706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    BURKE, INC.
    Date Received
    May 18, 1989
    Decision Date
    June 22, 1989
    Product Code
    ILO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILO Pack, Hot Or Cold, Water Circulating

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