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

    KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS

    K Number: K011859 · Decision May 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    2
    Review Days
    321

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    Basic Information

    Device Name
    KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
    K Number
    K011859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Klimamed Technologie Medizingerate GmbH
    Date Received
    June 14, 2001
    Decision Date
    May 1, 2002
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWJ System, Thermal Regulating

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    Other Clearances by Klimamed Technologie Medizingerate GmbH

    K Number Device Name
    K031728 KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET