BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ULTIMA AIRFLOW PRESSURE SENSOR

    K Number: K984431 · Decision Dec 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    8
    Review Days
    19

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    Basic Information

    Device Name
    ULTIMA AIRFLOW PRESSURE SENSOR
    K Number
    K984431
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Braebon Medical Corp.
    Date Received
    December 11, 1998
    Decision Date
    December 30, 1998
    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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    Other Clearances by Braebon Medical Corp.

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    K001743 ULTIMA SMARTBELT, MODEL 0560
    K981445 ULTIMA AIRFLOW SENSOR, 0510
    K982216 ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
    K981969 ULTIMA BODY POSITION SENSOR