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

    Isolette 8000 plus

    K Number: K172154 · Decision Apr 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    276

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    Basic Information

    Device Name
    Isolette 8000 plus
    K Number
    K172154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical Sytems, Inc.
    Date Received
    July 17, 2017
    Decision Date
    April 19, 2018
    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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