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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
    Type
    Traditional
    Panel
    Physical Medicine (PM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEO NEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "DeNovo Products Neo Nest Gel Infant Transport Mattress". It does not contain any information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The letter is a regulatory approval, not a scientific study report. It indicates that the device has been deemed "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market.

    Therefore, I cannot provide the requested information based on the provided text.

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