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

    LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER

    K Number: K951147 · Decision Jun 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER
    K Number
    K951147
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Leigh Med Tech, Inc.
    Date Received
    March 13, 1995
    Decision Date
    June 8, 1995
    Product Code
    CCW
    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
    CCW Laryngoscope, Rigid

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