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510(k) Data Aggregation

    K Number
    K233446
    Device Name
    AMC Health CareConsole
    Manufacturer
    AMC Health
    Date Cleared
    2024-09-27

    (344 days)

    Product Code
    MWI, DXH
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMC Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely viewed by healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition. · Data can be sent via intranet networks, the internet, landline telephones, and other mobile devices. · The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages. CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.
    Device Description
    The CareConsole ("CareConsole") is a software only device. CareConsole enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements, using third party devices, can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinicians can also use CareConsole to exchange messages with patients by text or telephone. The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.
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    K Number
    K151839
    Device Name
    AMC Health VitalCaregiving System
    Manufacturer
    AMC Health
    Date Cleared
    2016-09-09

    (431 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMC Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and store data, and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition. - Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices. • The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging. The VitalCaregiving System II is not intended for use in emergency situations or by a patient in an acute care medical facility and is not for active patient monitoring.
    Device Description
    The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is a software only device. VitalCaregiving System II enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements using third party devices can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinician. Clinicians can also use VitalCaregiving System II to exchange messages with patients by text or telephone. The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.
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