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

    KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)

    K Number: K964401 · Decision Feb 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    5
    Review Days
    94

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    Basic Information

    Device Name
    KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
    K Number
    K964401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ludlow Technical Products
    Date Received
    November 4, 1996
    Decision Date
    February 6, 1997
    Product Code
    FMT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMT Warmer, Infant Radiant

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