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

    VIBRALUNG ACOUSTICAL PERCUSSOR

    K Number: K133057 · Decision May 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    238

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    Basic Information

    Device Name
    VIBRALUNG ACOUSTICAL PERCUSSOR
    K Number
    K133057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Westmed, Inc.
    Date Received
    September 27, 2013
    Decision Date
    May 23, 2014
    Product Code
    SDT
    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
    SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices

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