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

    AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR

    K Number: K001057 · Decision May 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    397
    Applicant Total
    30
    Review Days
    30

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    Basic Information

    Device Name
    AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
    K Number
    K001057
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilent Technologies, Inc.
    Date Received
    April 3, 2000
    Decision Date
    May 3, 2000
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

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