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

    VITAL SYNC SYSTEM

    K Number: K123002 · Decision Feb 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    5
    Review Days
    153

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    Basic Information

    Device Name
    VITAL SYNC SYSTEM
    K Number
    K123002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, Formerly Nellcor Puritan Bennett, Inc.
    Date Received
    September 27, 2012
    Decision Date
    February 27, 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 Covidien, Formerly Nellcor Puritan Bennett, Inc.

    K Number Device Name
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    K092847 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
    K083693 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
    K082966 PB 540 VENTILATOR