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510(k) Data Aggregation

    K Number
    K030283
    Device Name
    BABY POD
    Manufacturer
    PRISM ENTERPRISES, INC.
    Date Cleared
    2003-04-22

    (85 days)

    Product Code
    FPP
    Regulation Number
    880.6900
    Why did this record match?
    Product Code :

    FPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.
    Device Description
    Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.
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