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

    MONTGOMERY TRACHEOSTOMY SPEAKING VALVE

    K Number: K955634 · Decision Jun 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    33
    Review Days
    182

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    Basic Information

    Device Name
    MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
    K Number
    K955634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Medical Products, Inc.
    Date Received
    December 11, 1995
    Decision Date
    June 10, 1996
    Product Code
    CBP
    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
    CBP Valve, Non-Rebreathing

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