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510(k) Data Aggregation

    K Number
    K993383
    Device Name
    HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    2000-02-03

    (118 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard Viridia M3/M4 (M3000A/M3046A) Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in the hospital and medical transport environments.
    Device Description
    The Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3015A (Viridia M3/M4, Rel. B.). The modification is the addition of a firmware and software based change that involves the addition of the M3015A Module to the portable Viridia M3/M4 Patient Monitor System to allow sidestream CO2, and a second invasive blood pressure and temperature measurements with the unit.
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    K Number
    K992273
    Device Name
    HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    2000-01-28

    (205 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard Viridia M3/M4 Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters' of adults, pediatrics, and neonates in the hospital and medical transport environments. 1. List of supported measurements ECG (a) Respiration (b) Invasive blood pressure (c) Non-invasive blood pressue ( વ ) SpO2 and Pleth (e) Temperature ( ) ) CO2 ( વે )
    Device Description
    The modification is the addition of a firmware and software based change that involves the addition of the M3016A Module to the portable Viridia M3/M4 Patient Monitor System to allow CO-Pressure, and Temperature measurements with the unit.
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    K Number
    K992595
    Device Name
    HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1999-12-08

    (127 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI™ ST segment Monitoring is indicated for: Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the
    Device Description
    The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI™ electrode system. The EASI™ capability is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.
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    K Number
    K992674
    Device Name
    HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1999-11-08

    (90 days)

    Product Code
    MHX, GWQ
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard Viridia CMS Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.
    Device Description
    The modification is the addition of new applications software and firmware that involves the addition of the M1027A EEG Module to the HP M1175A/76A/77A Component Monitoring System to allow the measurement of electroencephalographic signals.
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    K Number
    K990476
    Device Name
    HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1999-07-22

    (156 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI-ECG Option is indicated for: - Assessment of symptoms that may be related to rhythm disturbances of the heart: patients with palpitations, the evaluation of arrhythmia's in adult and pediatric patients. - Assessment of risk in patients with or without symptoms of arrhythmia. - Assessment of efficacy of antiarrhythmic therapy. - Assessment of pacemaker function. - Assessment of symptomatic or asymptomatic patients to evaluate for ischemic heart disease. - Assessment is indicated for single-hospital environment.
    Device Description
    The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI electrode system. The EASI option is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.
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    K Number
    K991773
    Device Name
    HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1999-06-07

    (13 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
    Device Description
    The Hewlett-Packard family of Viridia Patient Monitors individually known as the M3000A/M3046A (Viridia M3/4). The common name is patient monitor. The modification consists of the addition of software that involves only the arrhythmia and ST measurement algorithm of the measurement computer processing unit of each device.
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    K Number
    K990972
    Device Name
    HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1999-04-19

    (27 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
    Device Description
    The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M1175A/76A/77A (Viridia CMS), the M1205A (Viridia 24/26), and the M3000A/M3046A (Viridia M3/4). The common name is patient monitor. The modification is a software based change that involves only the SpO2 algorithm of the measurement computer processing unit of each device.
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    K Number
    K990125
    Device Name
    HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1999-01-29

    (16 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hewlett-Packard Viridia Component Monitoring System is intended for use in monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
    Device Description
    The modification is a software based change that combines software in the HP Clinical Monitoring System product line (M1175A, M1176A and M1177A, M100B/M1002B ECG/RESP) with the software in the HP Component Transport System Viridia, (M1205A), the devices are to be known collectively as the HP Viridia Component Monitoring System. The combination system will allow for shared future functionality capabilities in HP patient monitoring systems.
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    K Number
    K981576
    Device Name
    MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1998-07-17

    (74 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that: - Can measure and display multiple physiological parameters' and a) waves' of one patient, and can generate alarms and printouts based on those measurements. - Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets. - 1. List of supported measurements - (a) ECG - (b) Respiration - Invasive blood pressure (c) - Non-invasive blood pressure (d) - SpO2 and Pleth (e) - Temperature (f)
    Device Description
    The M3000A/M3046A Compact Portable Patient Monitor is intended for monitoring, and alarming of ECG, respiration, oxygen saturation, invasive and non-invasive pressure, and temperature. This [510(k)] modification adds a new feature (patient population) to the M3000A/M3046A Compact Portable Patient Monitor: the capability of monitoring neonatal patients is added to the noninvasive blood pressure measurement. The M3000A/M3046A Compact Portable Patient Monitor contains software.
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    K Number
    K971910
    Device Name
    MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
    Manufacturer
    HEWLETT-PACKARD GMBH
    Date Cleared
    1998-03-23

    (304 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEWLETT-PACKARD GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that: - Can measure and display multiple physiological parameters and waves' of a) one patient, and can generate alarms and printouts based on those measurements. - Can be used on adult, pediatric, and neonatal patients as specified in the b) Technical Data Sheets. The non-intrasive pressure can be used for adult and pediatric patients. - 1. List of supported measurements - ECG (a) - Respiration (b) - Invasive blood pressure (c) - Non-invasive blood pressure (d) - SpO2 and Pleth (e) - Temperature (f)
    Device Description
    M3000A/M3046A Compact Portable Patient Monitor
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