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

    FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM

    K Number: K971348 · Decision Feb 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    323

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    Basic Information

    Device Name
    FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
    K Number
    K971348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5650
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Green Field Medical Sourcing, Inc.
    Date Received
    April 10, 1997
    Decision Date
    February 27, 1998
    Product Code
    CAO
    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
    CAO Airway, Esophageal (Obturator)

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