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510(k) Data Aggregation

    K Number
    K173895
    Device Name
    Tel-O-Graph
    Date Cleared
    2019-05-16

    (511 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.E.M. Industrielle Entwicklung and Medizintechnik

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tel-O-Graph is intended for the home measurement of blood pressure and pulse on the upper arm in adults. The blood pressure monitor is suitable for individuals with an arm circumference of 20-55 cm (7.9-21.7 in) when used with the corresponding monitor cuff size. The data measured is automatically transmitted.
    Device Description
    The Tel-O-Graph is a table-top device for upper arm blood pressure measurements. The device employs the oscillometric principle for the non-invasive determination of the blood pressure from pressure signals obtained from the pressurized cuff placed around the upper arm. The device is operated via a single button to initiate blood pressure measurements. Data is transmitted automatically. The device is used by patients in a home environment.
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