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

    D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES

    K Number: K903730 · Decision Sep 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    127
    Applicant Total
    23
    Review Days
    40

    Basic Information

    Device Name
    D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
    K Number
    K903730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    CONCORD/PORTEX
    Date Received
    August 16, 1990
    Decision Date
    September 25, 1990
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by CONCORD/PORTEX

    K Number Device Name
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    K930286 DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
    K923127 NEEDLE-PRO CARTRIDGE
    K923910 HEAT MOISTURE CONDENSER
    K922749 LOW PROFILE TRACHEOSTOMY TUBE
    K922445 VACU-PRO
    K915452 ANESTHESIA BREATHING CIRCUIT
    K911809 NEW-VENT
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