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

    LIFENET EXCHANGE SYSTEM

    K Number: K052854 · Decision Jan 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    116
    Applicant Total
    6
    Review Days
    101

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LIFENET EXCHANGE SYSTEM
    K Number
    K052854
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Emergency Response Systems, Inc.
    Date Received
    October 11, 2005
    Decision Date
    January 20, 2006
    Product Code
    MSX
    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
    MSX System, Network And Communication, Physiological Monitors

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MSX), ordered by most recent decision date.

    IntelliVue Measurement Rack 6000 (867317)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TigerConnect Alarm Management

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BeneVision Central Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Central Station

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANNE View, Central Hub

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hinscope

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Medtronic Emergency Response Systems, Inc.

    K Number Device Name
    K063510 LIFEPAK 12 DEFIBRILLATOR/MONITOR
    K063119 LIFEPAK 20 DEFIBRILLATOR/ MONITOR
    K052057 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
    K042404 LIFEPAK, MODEL 1000
    K041459 LIFEPAK 12 DEFIBRILLATOR/MONITOR