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510(k) Data Aggregation

    K Number
    K011746
    Device Name
    MB 11
    Manufacturer
    MAICO DIAGNOSTIC GMBH
    Date Cleared
    2001-08-24

    (79 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Maico MB 11 is intended to generate evoked auditory brainstem response (ABR) - based measurements for both child and newborn hearing screening.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Maico MB 11" or "MB 11". This document primarily focuses on the regulatory approval process and includes the device’s indications for use. It does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document is a regulatory approval, not a scientific study report.

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