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

    Luma Wrap

    K Number: K142416 · Decision Jun 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    288

    Basic Information

    Device Name
    Luma Wrap
    K Number
    K142416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Salter Labs
    Date Received
    August 28, 2014
    Decision Date
    June 12, 2015
    Product Code
    PDH
    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
    PDH Blanket, Neonatal Phototherapy

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