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

    RESPIRATORY SENSOR

    K Number: K811014 · Decision Jun 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    27
    Review Days
    48

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    Basic Information

    Device Name
    RESPIRATORY SENSOR
    K Number
    K811014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Impact Instrumentation, Inc.
    Date Received
    April 15, 1981
    Decision Date
    June 2, 1981
    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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