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

    AIRTRAQ SP AIRTRAQ AVANT

    K Number: K121378 · Decision Jun 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    AIRTRAQ SP AIRTRAQ AVANT
    K Number
    K121378
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prodol Meditec , Ltd.
    Date Received
    May 8, 2012
    Decision Date
    June 21, 2012
    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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