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

    ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.

    K Number: K930790 · Decision Jan 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    45
    Review Days
    324

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    Basic Information

    Device Name
    ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
    K Number
    K930790
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Logic Systems Corp.
    Date Received
    February 16, 1993
    Decision Date
    January 6, 1994
    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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