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

    MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5

    K Number: K994188 · Decision May 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    158

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    Basic Information

    Device Name
    MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
    K Number
    K994188
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilent Technologies, GmbH
    Date Received
    December 13, 1999
    Decision Date
    May 19, 2000
    Product Code
    CBQ
    Advisory Committee
    Anesthesiology
    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
    CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

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    Other Clearances by Agilent Technologies, GmbH

    K Number Device Name
    K000822 AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR