BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE

    K Number: K002414 · Decision Sep 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    70
    Review Days
    49

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    Basic Information

    Device Name
    PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
    K Number
    K002414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Healthcare, Ltd.
    Date Received
    August 7, 2000
    Decision Date
    September 25, 2000
    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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