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

    MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER

    K Number: K971759 · Decision Mar 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    5
    Review Days
    294

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    Basic Information

    Device Name
    MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
    K Number
    K971759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Green Field Medical Sourcing, Inc.
    Date Received
    May 12, 1997
    Decision Date
    March 2, 1998
    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 Green Field Medical Sourcing, Inc.

    K Number Device Name
    K971348 FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
    K954150 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
    K944667 LIFE PULSE TESUSCITATION TIMER
    K932867 LIFE PULSE RESUSCITATION TIMER