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

    BREATHGUARD APNEA MONITOR

    K Number: K872833 · Decision Apr 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    7
    Review Days
    259

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    Basic Information

    Device Name
    BREATHGUARD APNEA MONITOR
    K Number
    K872833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Lada Intl., Inc.
    Date Received
    July 17, 1987
    Decision Date
    April 1, 1988
    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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