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

    DISPOSABLE INTUBATION KITS

    K Number: K921077 · Decision Aug 25, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    6
    Review Days
    176

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    Basic Information

    Device Name
    DISPOSABLE INTUBATION KITS
    K Number
    K921077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coast Medical Corp.
    Date Received
    March 2, 1992
    Decision Date
    August 25, 1992
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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    Other Clearances by Coast Medical Corp.

    K Number Device Name
    K930929 ESOPHAGEAL STETHOSCOPE
    K930930 COAST MEDICAL, INC. RECTAL PROBE
    K925781 DISPOSABLE CUFFED ENDOTRACHEAL TUBE
    K925855 DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
    K921353 NASOPHARYNGEAL AIRWAY