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    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101

    K Number: K040853 · Decision Jun 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
    K Number
    K040853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Hospital Supply Co.
    Date Received
    April 1, 2004
    Decision Date
    June 21, 2004
    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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