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

    RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL

    K Number: K864886 · Decision Mar 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
    K Number
    K864886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1850
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Nims/Respitrace Corp.
    Date Received
    December 12, 1986
    Decision Date
    March 6, 1987
    Product Code
    BZK
    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
    BZK Spirometer, Monitoring (W/Wo Alarm)

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