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

    ARTOCOOL-S WATER CIRCULATING COLD PACK

    K Number: K964354 · Decision Aug 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    2
    Review Days
    302

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    Basic Information

    Device Name
    ARTOCOOL-S WATER CIRCULATING COLD PACK
    K Number
    K964354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ormed GmbH
    Date Received
    October 31, 1996
    Decision Date
    August 29, 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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