BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COVA MONITORING SYSTEM

    K Number: K142087 · Decision May 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    275

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    Basic Information

    Device Name
    COVA MONITORING SYSTEM
    K Number
    K142087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tosense, Inc.
    Date Received
    July 30, 2014
    Decision Date
    May 1, 2015
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Tosense, Inc.

    K Number Device Name
    K160899 CoVa Monitoring System 2