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

    NUVON VITALS CHARTING SYSTEM

    K Number: K130234 · Decision Mar 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    301
    Applicant Total
    2
    Review Days
    42

    Basic Information

    Device Name
    NUVON VITALS CHARTING SYSTEM
    K Number
    K130234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NUVON, INC.
    Date Received
    January 30, 2013
    Decision Date
    March 13, 2013
    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 NUVON, INC.

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