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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hancock Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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