BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205

    K Number: K081498 · Decision Dec 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    202

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    Basic Information

    Device Name
    TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
    K Number
    K081498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocomfort Diagnostics GmbH & Co. KG
    Date Received
    May 29, 2008
    Decision Date
    December 17, 2008
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Biocomfort Diagnostics GmbH & Co. KG

    K Number Device Name
    K081499 HEALTH MANAGER, VERSION 1.1