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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Babyleo TN500

    K Number: K182859 · Decision Feb 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    134

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    Basic Information

    Device Name
    Babyleo TN500
    K Number
    K182859
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dragerwerk AG & CO Kgaa
    Date Received
    October 11, 2018
    Decision Date
    February 22, 2019
    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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