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

    NUVANT MCT SYSTEM

    K Number: K133701 · Decision Feb 6, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    7
    Review Days
    65

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    Basic Information

    Device Name
    NUVANT MCT SYSTEM
    K Number
    K133701
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corventis, Inc.
    Date Received
    December 3, 2013
    Decision Date
    February 6, 2014
    Product Code
    QYX
    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
    QYX Outpatient Cardiac Telemetry

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    Other Clearances by Corventis, Inc.

    K Number Device Name
    K113372 NUVANT, MOBILC CARDIAC TELEMETRY
    K113187 AVIVO MOBILE PATIENT MANAGEMENT
    K111917 NUVANT, MOBILE CARDIAC TELEMETRY
    K091971 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
    K090696 NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM
    K083287 AVIVO MOBILE PATIENT MANAGEMENT SYSTEM