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510(k) Data Aggregation

    K Number
    K080060
    Device Name
    VIVOSONIC NEUROSCREEN
    Manufacturer
    VIVOSONIC, INC.
    Date Cleared
    2008-04-04

    (86 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VIVOSONIC NEUROSCREEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary from the FDA for the Vivosonic NeuroScreen™ Infant Hearing Screener. It outlines the regulatory approval process and includes the indications for use.

    However, it does not contain any information about the acceptance criteria, the specific study conducted to prove device performance, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.

    Therefore, I cannot fulfill your request for this information based on the provided text.

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