BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A

    K Number: K003038 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    37
    Applicant Total
    4
    Review Days
    77

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    Basic Information

    Device Name
    AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
    K Number
    K003038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilent Technologies Deutschland GmbH
    Date Received
    September 29, 2000
    Decision Date
    December 15, 2000
    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 Agilent Technologies Deutschland GmbH

    K Number Device Name
    K002758 AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
    K001722 AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
    K001333 AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI