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

    T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

    K Number: K073675 · Decision May 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    27
    Review Days
    132

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    Basic Information

    Device Name
    T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
    K Number
    K073675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gaymar Industries, Inc.
    Date Received
    December 28, 2007
    Decision Date
    May 8, 2008
    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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