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

    MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE

    K Number: K022677 · Decision Sep 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    16
    Review Days
    30

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    Basic Information

    Device Name
    MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
    K Number
    K022677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alaris Medical Systems, Inc.
    Date Received
    August 12, 2002
    Decision Date
    September 11, 2002
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Alaris Medical Systems, Inc.

    K Number Device Name
    K043299 MEDLEY PCA MODULE, MODEL 8120
    K041241 MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
    K031741 MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
    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
    K022209 ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
    K013087 SINGLE DOSE DISPENSING PIN, MODEL 2201
    K012383 GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
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