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

    WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860

    K Number: K014121 · Decision Jan 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    42
    Review Days
    25

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    Basic Information

    Device Name
    WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
    K Number
    K014121
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett, Inc.
    Date Received
    December 17, 2001
    Decision Date
    January 11, 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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