BEUDAMED
    Product Code: QME FDA class 2 21 CFR 870.2785

    Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

    Cardiovascular

    The Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate is a cardiovascular software device that uses algorithms to analyze video signals and estimate vital sign parameters including pulse rate, heart rate, and respiratory rate. It is not intended to independently direct therapy and must be used adjunctively with clinical judgment. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.2785 in the Cardiovascular specialty. It carries product code QME and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    13
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    8
    Years Active
    5

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    Basic Information

    Product Code
    QME
    Device Class
    FDA class 2
    Regulation Number
    870.2785
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device 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 13 510(k) clearances via K numbers.

    K Number Device Name
    K254169 SmartSpectra Vital Signs Monitor 1.0
    K253650 Anura Mobile Core SDK (M1)
    K260066 PanopticAI Vital Signs (1.6.1-22)
    K251200 Vital Signs
    K243687 Vital Signs
    K250078 Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
    K240890 PanopticAI Vital Signs
    K241633 Informed Vital Core Application (IVC App)
    K232804 FibriCheck
    K223622 FaceHeart Vitals Software Development Kit (FH vitals SDK)
    K220899 Oxehealth Vital Signs
    K211906 Vital Signs
    DEN200019 Oxehealth Vital Signs

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.