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

    HYPER-K HEAT SYSTEM

    K Number: K912722 · Decision Sep 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    505
    Review Days
    85

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    Basic Information

    Device Name
    HYPER-K HEAT SYSTEM
    K Number
    K912722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Healthcare Corp
    Date Received
    June 18, 1991
    Decision Date
    September 11, 1991
    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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