BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE

    K Number: K944729 · Decision Dec 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    31
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
    K Number
    K944729
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5790
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coast Medical, Inc.
    Date Received
    September 26, 1994
    Decision Date
    December 21, 1994
    Product Code
    BSR
    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
    BSR Stylet, Tracheal Tube

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