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510(k) Data Aggregation

    K Number
    K190399
    Device Name
    Beddr 200 System
    Manufacturer
    Hancock Medical, Inc.
    Date Cleared
    2019-08-05

    (167 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Beddr 200 System is a reusable forehead reflectance sensor indicated for use in measuring and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spotchecking and/or data collection and recording of patients during no motion conditions, who are well perfused, in a home or healthcare environment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The text is an FDA 510(k) clearance letter for the Beddr 200 System, outlining the device's indications for use and general regulatory information. It does not include specific performance criteria, study design, sample sizes, expert qualifications, or ground truth methodologies that you have requested.

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