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

    INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET

    K Number: K973023 · Decision Nov 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    85
    Review Days
    81

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    Basic Information

    Device Name
    INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
    K Number
    K973023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hollister, Inc.
    Date Received
    August 14, 1997
    Decision Date
    November 3, 1997
    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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