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

    PERCUSSIVENEB, MODEL PN-2001

    K Number: K003684 · Decision Feb 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    24
    Applicant Total
    28
    Review Days
    86

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    Basic Information

    Device Name
    PERCUSSIVENEB, MODEL PN-2001
    K Number
    K003684
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortran Medical Technology 1, Inc.
    Date Received
    November 29, 2000
    Decision Date
    February 23, 2001
    Product Code
    NHJ
    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
    NHJ Device, Positive Pressure Breathing, Intermittent

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