BEUDAMED
    Product Code: QNL FDA class 2 21 CFR 870.2210

    Medium-Term Adjunctive Predictive Cardiovascular Indicator

    Cardiovascular

    The Medium-Term Adjunctive Predictive Cardiovascular Indicator is a prescription software device that uses algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period, intended for adjunctive use alongside other vital sign parameters and patient information, and is not intended to independently direct therapy. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.2210 in the Cardiovascular specialty. It carries product code QNL and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    5
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    4
    Years Active
    3

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    Basic Information

    Product Code
    QNL
    Device Class
    FDA class 2
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K233253 eCARTv5 Clinical Deterioration Suite (“eCART”)
    K233216 CLEWICU System
    K230842 SignalHF (IM008)
    K231038 Global Hypoperfusion Index (GHI) Algorithm
    K200717 CLEWICU System (ClewICUServer and ClewICUnitor)

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.