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

    SINGLE DOSE DISPENSING PIN, MODEL 2201

    K Number: K013087 · Decision Nov 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    16
    Review Days
    57

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    Basic Information

    Device Name
    SINGLE DOSE DISPENSING PIN, MODEL 2201
    K Number
    K013087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alaris Medical Systems, Inc.
    Date Received
    September 17, 2001
    Decision Date
    November 13, 2001
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Alaris Medical Systems, Inc.

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    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
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