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

    PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP

    K Number: K884133 · Decision Mar 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    9
    Review Days
    159

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    Basic Information

    Device Name
    PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
    K Number
    K884133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Preemicare Corp.
    Date Received
    September 30, 1988
    Decision Date
    March 8, 1989
    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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    Other Clearances by Preemicare Corp.

    K Number Device Name
    K911450 INFANT VENTILATOR
    K896375 PREEMICARE NEBUTECH NEBULIZER SYSTEM
    K900735 MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
    K893622 PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
    K893624 PREEMICARE MODEL 2500 TRANSPORT WARMER
    K891674 NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
    K885350 PREEMICARE SERIES 2000 INFANT WARMER
    K881476 PREEMICARE MODEL D1-X1, SERIES 3000