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

    TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)

    K Number: K962944 · Decision Oct 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
    K Number
    K962944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Transtracheal Systems
    Date Received
    July 26, 1996
    Decision Date
    October 23, 1996
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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    Other Clearances by Transtracheal Systems

    K Number Device Name
    K982943 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
    K981078 TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
    K981080 SCOOP 1
    K904748 TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
    K904749 TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
    K902281 MODIFIED SCOOP TRANSTRACHEAL CATHETERS
    K854252 TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER