BEUDAMED
    Product Code: QYF FDA class 2 21 CFR 870.1130

    Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

    Cardiovascular

    The neonatal ICU continuous non-invasive blood pressure monitor (product code QYF) is a Class 2 Cardiovascular prescription device (regulation 870.1130) used by medical professionals to measure non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. Requiring 510(k) clearance, the device requires calibration, is intended for use in conjunction with SpO2 monitoring, and is not indicated for ambulatory monitoring. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    QYF
    Device Class
    FDA class 2
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring.