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

    BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524

    K Number: K062533 · Decision Dec 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    8
    Review Days
    115

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    Basic Information

    Device Name
    BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524
    K Number
    K062533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurovirtual USA, Inc.
    Date Received
    August 29, 2006
    Decision Date
    December 22, 2006
    Product Code
    OLT
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLT Non-Normalizing Quantitative Electroencephalograph Software

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