BEUDAMED
    Product Code: PFY FDA class 2 21 CFR 870.2300

    Low Patient Acuity Monitoring System

    Cardiovascular

    The Low Patient Acuity Monitoring System is a cardiovascular monitoring device intended for non-continuous central monitoring of patient parameters, including cardiac parameters, in low-risk patients. It is an FDA Class 2 device regulated under 21 CFR 870.2300, requiring 510(k) premarket notification, within the Cardiovascular (CV) specialty. The product code is PFY. This device 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
    PFY
    Device Class
    FDA class 2
    Regulation Number
    870.2300
    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

    For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients.