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

    ANESTHETIC AGENT MONITOR

    K Number: K892854 · Decision Oct 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    22
    Review Days
    178

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    Basic Information

    Device Name
    ANESTHETIC AGENT MONITOR
    K Number
    K892854
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Criticare Systems, Inc.
    Date Received
    April 18, 1989
    Decision Date
    October 13, 1989
    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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