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

    neoBLUE blanket LED Phototherapy System

    K Number: K182178 · Decision Dec 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    10
    Review Days
    122

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    Basic Information

    Device Name
    neoBLUE blanket LED Phototherapy System
    K Number
    K182178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical Incorporated
    Date Received
    August 13, 2018
    Decision Date
    December 13, 2018
    Product Code
    LBI
    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
    LBI Unit, Neonatal Phototherapy

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