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

    OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER

    K Number: K892057 · Decision Apr 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    120
    Review Days
    28

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    Basic Information

    Device Name
    OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
    K Number
    K892057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Ohmeda Medical
    Date Received
    March 29, 1989
    Decision Date
    April 26, 1989
    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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