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

    A-LINE AEP MONITOR

    K Number: K010965 · Decision Jun 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    37
    Applicant Total
    16
    Review Days
    86

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    Basic Information

    Device Name
    A-LINE AEP MONITOR
    K Number
    K010965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alaris Medical Systems, Inc.
    Date Received
    April 2, 2001
    Decision Date
    June 27, 2001
    Product Code
    OLW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLW Index-Generating Electroencephalograph Software

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    Other Clearances by Alaris Medical Systems, Inc.

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    K032233 MEDLEY PCA MODULE, MODEL 8120
    K032147 SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
    K030459 MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
    K023264 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
    K022677 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
    K022209 ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
    K013087 SINGLE DOSE DISPENSING PIN, MODEL 2201
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