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510(k) Data Aggregation

    K Number
    K040799
    Device Name
    HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2004-08-18

    (142 days)

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

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HomMed Genesis Patient Monitor with Options is a system designed to monitor patient vital signs at home and/or in healthcare facilities. Vital signs include pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products including glucose meter, spirometer, and prothrombin time can be exported via the Genesis communication module. Vital signs data is transmitted via modem to a central viewing station for display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status.
    Device Description
    The HomMed Genesis Patient Monitor System with Options (HomMed Genesis) is a portable patient vital signs monitoring system. The system measures pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. HomMed Genesis will have four serial ports available for external options. The Genesis acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.
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    K Number
    K040651
    Device Name
    HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2004-08-10

    (152 days)

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

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HomMed Sentry IIIB-F Patient Monitor System is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry IIIB-F Patient Monitor System is available with physicians' orders only. The HomMed Sentry IIIB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SpO₂), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry IIIB-F Patient Monitor System's optional, compatible devices extend those measurements to glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) monitoring and digital image acquisition. The patient parameter data is collected and displayed by the HornMed Sentry IIIB-F Patient Monitor System. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed.
    Device Description
    The HomMed Sentry IIIB-F Patient Monitor System (Sentry IIIB-F) is a portable patient vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) measuring, and digital image acquisition capabilities. The Sentry IIIB-F acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis. Sentry IIIB-F provides a noninvasive blood pressure (NIBP) monitor for measurements of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures; pulse oximeter, acquires a pulse rate using an oximeter; oral temperature via an electronic thermometer; weight from an electronic scale. All data collected from these functions as well as optional glucometry, ECG devices, PT/INR monitor and acquired digital images are sent through an internal communication module.
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    K Number
    K040032
    Device Name
    CENTRAL STATION, VERSION 3.3H
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2004-02-27

    (50 days)

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

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HomMed Central Station intended use is to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric (over 12 years of age) patients within healthcare and home environments. Central Station, Version 3.3H includes a HL7 interface to transfer data from HomMed Central Station to vendor systems and storage media. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature, and weight. Additionally monitoring device data from optional commercial stand-alone products including glucometry, spirometry, prothrombin time, ECG and digital camera images can also be received, displayed and stored. The Central Station displays patient data and system alerts for review and interpretation by physicians and/or physician supervised nurses. Central Station is a retrospective data monitor system and is not intended for emergency use or real-time monitoring.
    Device Description
    The HomMed Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. The HomMed Central Station is a software system that accepts data from the HomMed Sentry Patient Monitors.
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    K Number
    K020184
    Device Name
    HOMMED CENTRAL STATION
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2002-04-22

    (94 days)

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

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HomMed Central Station is intended to be used to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the monitored patient data, and the healthcare professional is responsible for the interpretation of the monitored data made available by the Observer. The Central Station data will be a utilized by the healthcare professional health including physicians and/or physician supervised nurses. Physiological data, system alerts and patient data analysis will be available to the health care provider from Central Station that may be considered as a retrospective data monitor system.
    Device Description
    The HomMed Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. The HomMed Central Station is a software system that is an accessory to the HomMed Sentry Patient Monitors.
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    K Number
    K014025
    Device Name
    HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2002-04-09

    (124 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HomMed Sentry III Patient Monitor System with Card Reader is intended for in home and/or healthcare facility applications under physician orders. The Card Reader with the HomMed Sentry III Patient Monitor System allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor. The use of the system is to allow retrospective review of certain patient physiological functions. The HomMed Sentry III Patient Monitor System with Card Reader can measure and display patient data including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. Additionally, the patient vital signs data can be communicated to a central review station via a pager network with a backup landline telephone modem for telephone communication with the central pager network if necessary.
    Device Description
    The HomMed Sentry III Patient Monitor System with Card Reader is a portable patient vital signs monitoring system which allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometry and spirometer measuring capabilities. The Sentry III Patient Monitor with Card Reader acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel Pager Network to a central station for storage with retrospective display and analysis. The Card Reader with the HomMed Sentry III Patient Monitor System allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor.
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    K Number
    K003180
    Device Name
    HOMMED OBSERVER, MODEL I
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2001-06-28

    (260 days)

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

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K004044
    Device Name
    HOMMED SENTRY III PATIENT MONITOR SYSTEM
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2001-03-02

    (63 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993938
    Device Name
    THE HOMMED SENTRY, MODEL 1 SENTRY
    Manufacturer
    HOMMED LLC.
    Date Cleared
    2000-03-15

    (117 days)

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

    HOMMED LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HomMed Model Sentry patient monitor system is for spot checking of adult or pediatric patient's systolic, diastolic and mean arterial (MAP) blood pressures, pulse rate, SpO2 oximetry and oral temperature. The device will provide fast, reliable NIBP measurements on patients when using the appropriate blood pressure cuff. The oximetry function operates with all OEM (BCI) oximetry sensors, providing SpO2 and pulse rate on all patients from pediatric to adult patients. The electronic thermometry is intended for oral temperature measurements and is only compatible with the Welch Allyn thermometry probes and probe covers. The device is intended for use in clinical environments by health care providers and for home use by patients with retrospective review by health care providers.
    Device Description
    HomMed Model Sentry patient monitor provides a manually initiated sequence of automatic patient measurements. The Sentry patient monitor consists of a small tabletop NIBP monitor with a desktop Features include an NIBP cuff hose connection, an SpO2 sensor interface, a oral charger. temperature probe interface and holder, display of patient systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature via an LED display. The HomMed Model Sentry is the existing presently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with oximeter and electronic thermometer options with certain defeatures implemented via software toggle off/on function controls. The BCI Mini-Torr Plus monitor has a FDA 510(k) approval, Number K983796.
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