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

    COMEN MULTI-PARAMETER PATIENT MONITOR

    K Number: K112877 · Decision Nov 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    404

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    Basic Information

    Device Name
    COMEN MULTI-PARAMETER PATIENT MONITOR
    K Number
    K112877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Goldway (Us), Inc.
    Date Received
    September 30, 2011
    Decision Date
    November 7, 2012
    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 Goldway (Us), Inc.

    K Number Device Name
    K033988 GOLDWAY UT4000A VITAL SIGNS MONITOR