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510(k) Data Aggregation

    K Number
    K112547
    Device Name
    NEO NEST
    Manufacturer
    DENOVO PROUCTS LLC
    Date Cleared
    2012-03-06

    (187 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENOVO PROUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.
    Device Description
    Neo Nest Infant Transport Mattress
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