BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    VISENSIA, VISENSIA WITH ALERT

    K Number: K110953 · Decision Jun 15, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    3
    Review Days
    71

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    Basic Information

    Device Name
    VISENSIA, VISENSIA WITH ALERT
    K Number
    K110953
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Obs Medical
    Date Received
    April 5, 2011
    Decision Date
    June 15, 2011
    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 Obs Medical

    K Number Device Name
    K081140 VISENSIA
    K071606 BIOSIGN CENTRAL STATION