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

    DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC

    K Number: K990132 · Decision Jan 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    58
    Review Days
    7

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    Basic Information

    Device Name
    DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
    K Number
    K990132
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex-Ohmeda, Inc.
    Date Received
    January 14, 1999
    Decision Date
    January 21, 1999
    Product Code
    CAD
    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
    CAD Vaporizer, Anesthesia, Non-Heated

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