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

    AVIVO MOBILE PATIENT MANAGEMENT

    K Number: K113187 · Decision Jan 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    7
    Review Days
    65

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    Basic Information

    Device Name
    AVIVO MOBILE PATIENT MANAGEMENT
    K Number
    K113187
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corventis, Inc.
    Date Received
    October 31, 2011
    Decision Date
    January 4, 2012
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Corventis, Inc.

    K Number Device Name
    K133701 NUVANT MCT SYSTEM
    K113372 NUVANT, MOBILC CARDIAC TELEMETRY
    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