BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000

    K Number: K050524 · Decision Sep 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    196

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    Basic Information

    Device Name
    EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
    K Number
    K050524
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marda Medical, Inc.
    Date Received
    March 2, 2005
    Decision Date
    September 14, 2005
    Product Code
    IRQ
    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
    IRQ Unit, Heating, Powered

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