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

    PALMO THERMOREGULATION INTERFACE ACCESSORY

    K Number: K014210 · Decision Aug 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    2
    Review Days
    238

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    Basic Information

    Device Name
    PALMO THERMOREGULATION INTERFACE ACCESSORY
    K Number
    K014210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avacore Technologies, Inc.
    Date Received
    December 21, 2001
    Decision Date
    August 16, 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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