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

    ULTIMA BODY POSITION SENSOR

    K Number: K981969 · Decision Aug 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    18
    Applicant Total
    8
    Review Days
    77

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ULTIMA BODY POSITION SENSOR
    K Number
    K981969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Braebon Medical Corp.
    Date Received
    June 4, 1998
    Decision Date
    August 20, 1998
    Product Code
    LEL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LEL Device, Sleep Assessment

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LEL), ordered by most recent decision date.

    EmbraceMini

    FDA 510(k)
    FDA Class 2 ·Neurology

    Sleep Watch

    FDA 510(k)
    FDA Class 2 ·Neurology

    DCM (PW-DCM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VERABAND™

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oxevision Sleep Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    ActiGraph LEAP activity monitor (ActiGraph LEAP)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Braebon Medical Corp.

    K Number Device Name
    K061764 MEDIBYTE, MODEL MP8
    K031202 MEDIPALM-20
    K020312 ULTIMA SNORING MIKE, MODEL 0540
    K001743 ULTIMA SMARTBELT, MODEL 0560
    K984431 ULTIMA AIRFLOW PRESSURE SENSOR
    K981445 ULTIMA AIRFLOW SENSOR, 0510
    K982216 ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522