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

    SMARTVEST AIRWAY CLEARANCE SYSTEM

    K Number: K132794 · Decision Dec 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    57
    Applicant Total
    5
    Review Days
    104

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    Basic Information

    Device Name
    SMARTVEST AIRWAY CLEARANCE SYSTEM
    K Number
    K132794
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electromed, Inc.
    Date Received
    September 6, 2013
    Decision Date
    December 19, 2013
    Product Code
    BYI
    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
    BYI Percussor, Powered-Electric

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    Other Clearances by Electromed, Inc.

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