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

    PATIENT WARMER MODEL 100C

    K Number: K910915 · Decision Jul 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    PATIENT WARMER MODEL 100C
    K Number
    K910915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Developmed Corp.
    Date Received
    March 5, 1991
    Decision Date
    July 16, 1991
    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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