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

    INCUBATOR 8000 SC

    K Number: K914134 · Decision Nov 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    84
    Applicant Total
    1
    Review Days
    115

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    Basic Information

    Device Name
    INCUBATOR 8000 SC
    K Number
    K914134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Draeger, Inc.
    Date Received
    July 30, 1991
    Decision Date
    November 22, 1991
    Product Code
    FMZ
    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
    FMZ Incubator, Neonatal

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