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

    Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535

    K Number: K192092 · Decision Jan 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    2
    Review Days
    171

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    Basic Information

    Device Name
    Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
    K Number
    K192092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seca GmbH & Co. KG
    Date Received
    August 5, 2019
    Decision Date
    January 23, 2020
    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 Seca GmbH & Co. KG

    K Number Device Name
    K122388 SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514