BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

    K Number: K072295 · Decision Oct 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
    K Number
    K072295
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oridion Capnography, Inc.
    Date Received
    August 16, 2007
    Decision Date
    October 11, 2007
    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 Oridion Capnography, Inc.

    K Number Device Name
    K101995 CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
    K094012 CAPNOSTREAM20 WITH MICROMEDICO2 MODULE
    K082268 CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
    K060065 CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR