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

    DATEX-ENGSTROM NETWORK

    K Number: K974101 · Decision Feb 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    116
    Applicant Total
    9
    Review Days
    99

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    Basic Information

    Device Name
    DATEX-ENGSTROM NETWORK
    K Number
    K974101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Datex-Engstrom, Inc.
    Date Received
    October 30, 1997
    Decision Date
    February 6, 1998
    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

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    Other Clearances by Datex-Engstrom, Inc.

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    K980362 MRI COMPATIBLE MONITOR AND ACCESSORIES
    K974792 CS/3(TM) MONITORS*
    K980384 TRIP TONOMETRY CATHETER, 18F
    K974747 CS/3 ARRHYTHMIA WORKSTATION