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

    ENDEAVOUR MONITORING SYSTEM

    K Number: K102004 · Decision Sep 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    3
    Review Days
    57

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    Basic Information

    Device Name
    ENDEAVOUR MONITORING SYSTEM
    K Number
    K102004
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mindray DS USA, Inc.
    Date Received
    July 15, 2010
    Decision Date
    September 10, 2010
    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 Mindray DS USA, Inc.

    K Number Device Name
    K132026 V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
    K102471 AS3700 ANESTHSIA DELIVERY SYSTEM