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510(k) Data Aggregation

    K Number
    K191745
    Device Name
    Medtronic Commander Flex
    Date Cleared
    2020-05-15

    (319 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medtronic Care Management Services

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
    Device Description
    Commander Flex devices are home health monitoring tools typically used by patients with diseases such as congestive heart failure (CHF), diabetes, chronic obstructive pulmonary disease (COPD) asthma and coronary artery disease (CAD). Patients use Commander Flex to collect and send important health information to their health care team to allow a doctor and other health care team members to act before symptoms worsen. Commander Flex devices have a built-in non-invasive blood pressure measurement system that measures systolic and diastolic blood pressure and displays the readings on the Commander Flex panel. In addition to making blood pressure and heart rate measurements, Commander Flex devices store and transmit data from peripheral devices to remote locations. Commander Flex connects to a user's home phone line or cellular network. It has inputs for peripheral devices such as weight scales, glucose meters, pulse oximeters, thermometers and blood pressure cuff. The display asks health-related questions to obtain objective biometric data such as: weight, blood pressure, glucose, and pulse oximetry. Patients may also answer a series of questions about their current symptoms. The patient can respond Yes or No or select from a list. Commander Flex devices collect data from peripherals and transmit the data using a cellular connection or toll-free telephone number and modelar design of the Commander Flex device allows for selection of the appropriate health monitoring devices for cost-effective patient care. Commander Flex products are for home use. This 510(k) clearance achieves OTC designation for Commander Flex devices. The peripheral devices are used as supplied by the manufacturer. The Commander Flex devices make no interpretation, evaluation, medical judgements or recommendations for treatment. Commander Flex is not used as an emergency response device. Clinical judgment and experience are required to interpret the information transmitted. Commander Flex devices are not intended as a substitute for medical care.
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