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

    EEG & RESPIRATION MODULES POLYGRAPH

    K Number: K823563 · Decision Jan 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    166
    Review Days
    41

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    Basic Information

    Device Name
    EEG & RESPIRATION MODULES POLYGRAPH
    K Number
    K823563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    December 2, 1982
    Decision Date
    January 12, 1983
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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