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510(k) Data Aggregation

    K Number
    K091021
    Device Name
    MODIFICATION TO MEDICOMPASS CONNECT
    Manufacturer
    IMETRIKUS, INC.
    Date Cleared
    2009-07-15

    (97 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMETRIKUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediCompass® Connect serves as an interface or a gateway between personal monitoring devices and a general-purpose personal health management database. The MediCompass Connect collects physiologic measurements and retrospectively monitors vital signs from defined personal monitoring devices and transmits the data to a central database server, using standard communication technologies. MediCompass Connect is designed for professional, personal and home use. MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.
    Device Description
    MediCompass® Connect is a telehealth gateway to upload biometric data from personal health monitoring devices, including glucose monitors, insulin pumps, blood pressure monitors, digital spirometers, pulse oximeter, PT/INR meter, activity monitor/pedometer, and weight scales. The system conveniently transfers data via a standard phone line or Internet-enabled personal computer using the MetrikLink® connectivity hub, or connection directly to mobile devices via wireless technology. After connectivity is activated by a health care professional, patients can connect their monitoring device to MediCompass Connect using MetrikLink, adapters or compatible cables provided for their specific medical device and model. The data captured from the personal monitoring medical devices is transferred securely to the MediCompass database or other secure online database, then to the health care provider's remote general purpose health management database. MediCompass Connect does not provide diagnosis of any disease or medical condition, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. MediCompass Connect is not intended for emergency use or for transmission or indication of any real-time alarms or time critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
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    K Number
    K042768
    Device Name
    MEDICOMPASS CONNECT
    Manufacturer
    IMETRIKUS, INC.
    Date Cleared
    2005-02-22

    (140 days)

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

    IMETRIKUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to: - Blood glucose monitor - Blood pressure cuffs I - Insulin pumps - Spirometers - . Scales MediCompass Connect is designed for professional healthcare settings and home use.
    Device Description
    MediCompass Connect is a system that transmits data from personal monitoring devices using standard communication methods such as telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet. MediCompass Connect transmits the data from a personal monitoring devices, such as a blood pressure cuff, to a remote general-purpose personal health management database. - Blood pressure cuffs . - . Blood glucose meters - Insulin pumps . - Spirometers . - . Scales
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