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510(k) Data Aggregation

    K Number
    K221056
    Device Name
    ARGUS PB-3000
    Manufacturer
    SCHILLER AG
    Date Cleared
    2023-07-06

    (451 days)

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

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient. Indicated for the following applications: ECG monitoring and diagnostic - The ECG monitoring function provide a conventional information about the patient's ECG rhythm, heart rate, and may be used for the diagnostic measurements, interpretation and arrhythmias detection in a medical device or medical system (Host System). Respiration rate and apnea monitoring is indicated for pneumatic issues. IBP - Invasive blood pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis. NIBP - NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure. SpO2 - These measurements are indicated for use in patients who are at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. This monitoring may be used during no motion conditions, and in patients who are well or poorly perfused. CO2 - The CO2 measurement is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. Respiration rate and apnea monitoring is indicated for pneumatic issues. Cardiac Output (CO) - Cardiac Output measurement is indicated for use in patients who require a non-continuous measurement of the stroke volume and 1/min volume of the heart. Temperature - Temperature measurement is indicated in any patient that has a risk of high or low temperature.
    Device Description
    The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, and transmission of patient vitals and other pertinent clinical data. It receives vital signals from the patient through external sensors and communicates with the Host System. Data is transmitted to the Host System via network connection and without storing vital data and patient demographic data on the PB-3000. Depending on the variant of the PB-3000, the device has different modules allowing measurement of the vital parameter for ECG (monitoring and diagnostic mode, and respiration), IBP, temperature, cardiac output (CO), Sp02, CO2, and/or NIBP measurements. The Host System is designed by a 3rd party host system manufacturer who chooses the PB-3000 variant to be implemented in their Host System. The PB-3000 communication interface allows the Host System Manufacturer to setup and use the provided functions.
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    K Number
    K183425
    Device Name
    CARDIOVIT AT-102 G2
    Manufacturer
    Schiller AG
    Date Cleared
    2020-03-02

    (447 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Schiller AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms. The CARDIOVIT AT-102 G2 is designed for indoor use and can be used for all patient populations. The CARDIOVIT AT-102 G2 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients. The CARDIOVIT AT-102 G2 is intended for use in hospitals, cardiology units, outpatient clinical units and general physician's offices.
    Device Description
    The CARDIOVIT AT-102 G2 is a 12-channel ECG unit used for the recording, analysis, viewing, storage and transmission of ECG waveforms.
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    K Number
    K170182
    Device Name
    CARDIOVIT FT-1
    Manufacturer
    SCHILLER AG
    Date Cleared
    2017-07-19

    (177 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARDIOVIT F - 1 is a 12-channel ECG unit used for the recording, viewing, storage and transmission of ECG waveforms. The CARDIOVIT FT-1 is designed for indoor use and can be used for all patient populations. The CARDIOVIT FT-1 is used to diagnose cardiac abnormalities, and detect acute myocardial ischemia and infarctions in chest pain patients. The CARDIOVIT FT-1 is intended for use in hospitals, cardiology units, out-patient clinical units and general physician's offices.
    Device Description
    The CARDIOVIT FT-1 is a 12-lead ECG (Electrocardiograph) device used in the recording, analysis, viewing, storage and transmission of ECG waveforms. The CARDIOVIT FT-1 does not provide a patient monitoring capability with alarm annunciation. The CARDIOVIT FT-1 has a color display. It accepts user input via a touch panel or barcode scanner. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder that is built into the device. The CARDIOVIT FT-1 is mains- or battery- powered and uses sensors that come in contact with the patient. The CARDIOVIT FT-1 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.
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    K Number
    K152043
    Device Name
    Diagnostic Station DS20
    Manufacturer
    SCHILLER AG
    Date Cleared
    2016-05-06

    (288 days)

    Product Code
    DPS, BZG, BZQ, DQA, DXN, FLL, JKS, MWI
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions. The DS20 also measures the following patient vital information to further assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight. The DS20 is intended for data collection only. It is not intended for continuous momitoring use and does not provide an alarm function. The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.
    Device Description
    The Diagnostic Station DS20 is a 12-lead EGG (Electrocardiograph) device used for the recording, analysis and evaluation of ECG waveforms. It also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO>), carboxyhemoglobin saturation (SpCO), respiration, temperature and weight. It also supports a 5-lead ECG measurement of heart rate when 12-lead ECG analysis is not needed. The DS20 does not provide a patient monitoring capability with alarm annunciation. The DS20 has a color display. It accepts user input via a touch panel, barcode scanner or keyboard. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder or laser printer. The DS20 is mains- or battery-powered and uses sensors that come in contact with the patient. The DS20 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.
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    K Number
    K101619
    Device Name
    WELCH ALLYN 1500 PATIENT MONITOR
    Manufacturer
    SCHILLER AG
    Date Cleared
    2010-11-12

    (156 days)

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

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the monitoring of vital parameters such as ECG, SpO2, etCO2, non invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature and respiration of a patient. The device is intended to be used by qualified doctors or trained medical personnel. The device is not suitable for transport. There is no danger for patients with pacemaker. The device is intended for the monitoring of one patient at a time. The device is not designed for sterile use nor is it designed for outdoor use. Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases. The device is classified CF. It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation. This product is not designed for direct cardiac application. The arrhythmia module is not intended for use with neonatal patients. The ST-analysis module is not intended for use with neonatal patients.
    Device Description
    The Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for neonates, children, adult and paediatric use. It has a LCD screen for comprehensive vital data monitoring. Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor also provides full vital data monitoring during transport with the built-in battery.
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    K Number
    K063814
    Device Name
    BP-200 PLUS
    Manufacturer
    SCHILLER AG
    Date Cleared
    2007-03-07

    (75 days)

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

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The measurement cuff of the BP-200 plus in intended to be placed on the upper right arm of the patient. The BP-200 plus can be used for patients of both sexes and all races. The BP-200 plus should not be used with neonates.
    Device Description
    The BP-200 plus, a microprocessor based non invasive blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical ear sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by a valve. The BP-200 plus has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second. The BP-200 plus is powered by an external power supply (input: 230/110 V; output: 9V dc), and as an option by using four "AA" rechargeable batteries (≥ 2500 mAh). The batteries must be recharged with an external battery charger.
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    K Number
    K053207
    Device Name
    ARGUS, MODEL LCM
    Manufacturer
    SCHILLER AG
    Date Cleared
    2006-05-19

    (184 days)

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

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: - ECG: Heartrate, Respiration Rate ・ - Invasive Blood Pressure: systolic, diastolic and mean pressure - - Temperature: temperature ー - Non Invasive Blood Pressure: systolic, diastolic and mean pressure - - CO2, etCO2 and CO2ins - - SpO2: SpO2 and pulse rate - There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
    Device Description
    The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: ECG, Invasive Blood Pressure, Temperature, Non Invasive Blood Pressure, CO2, etCO2, CO2ins, SpO2, and pulse rate. There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. The system is intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
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    K Number
    K051368
    Device Name
    BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
    Manufacturer
    SCHILLER AG
    Date Cleared
    2005-08-09

    (76 days)

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

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races. The BR-102 plus should not be used with neonates.
    Device Description
    The BR-102 plus is a portable, compact, lightweight, microprocessor based ambulatory blood pressure monitor. Two versions are available: - Using auscultatoric and oscillometric signals. During cuff delfation auscultatoric and . oscillometric signals are analysed by the microprocessor to determine the blood pressure, where the oscillometric measurement is used as a backup. - Purely oscillometric method to use the device without a microphone. The oscillometric . signals are analysed by the microprocessor to determine the blood pressure. The device is worn or carried by the patient. The cuff is borne on the upper arm. An electrical pump inside the device generates the pressure in the cuff. The BR-102 plus is powered from two AA size recharchable NiMH batteries. The BR-102 plus initialises blood pressure measurements depending on a predetermined shedule (normally predetermined by a physician), or on demand (by using the start key). Each reading is stored in memory, allowing the physician to download all the results obtained during the study period after the study has concluded, to be analysed by the PC software. The readings are displayed on the display for a short time. The associated MT-300 PC software provides the setup of the system. A measurement shedule can be defined with the MT-300 program and up-loaded into the BR-102 plus. All the settings can also be made on the device. After the ambulatory blood pressure study has been completed (up to 48h) the stored readings in the BR-102 plus are downloaded to the PC using the MT-300 program. The MT-300 programm provides the data in tabular and graphic form, as well as a patient report and statistical values.
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    K Number
    K050686
    Device Name
    CARDIOVIT AT-10PLUS
    Manufacturer
    SCHILLER AG
    Date Cleared
    2005-05-04

    (49 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AT-10Plus is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-10Plus can be used as a diagnostic aid for heart function and heart conditions. The AT-10Plus is designed for indoor use. The device provide an optional interface to the SP-250 for pulmonary function data.
    Device Description
    The AT-10Plus is a 12-channel, ECG device used for the recording, analysis and evaluation of ECG recordings. It has dimensions of 348x288x87mm and weighs 4.2 Kg. It operates in temperatures from +10° - 40° C and storage temperatures from -10° - +50° C, with relative humidity between 25% - 95% (non condensing). It supports Standard / Cabrera leads and has a battery capacity of 2 hrs of normal use. The frequency range of the digital recorder is 0 to 150Hz. It has an Alphanumerics, LCD Display 800x600dots. The Myogram Filter is 25Hz or 35Hz programmable. Paper speeds are 5/10/12.5/25/50 mm/s. The printing process uses a High resolution thermal printhead 8dots per mm 200dots per inch(amplitude axes) 40dots per mm / 1000 dots per inch time axes, 25mm/s. It uses Thermoreactive, Z-folded, 210mm chart paper and has 6 recording tracks, positioned at optimal with on 80 mm / 3.2 inch automatic baseline adjustement. It has 6 channel representation of 12 simultaneously acquired standard leads automatic lead programs. It also provides an optional interface to the SP-250 for spirometry.
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    K Number
    K033738
    Device Name
    MONITORING SYSTEM, MODEL ARGUS PB-2200
    Manufacturer
    SCHILLER AG
    Date Cleared
    2004-08-24

    (270 days)

    Product Code
    DSK
    Regulation Number
    870.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHILLER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as: Invasive blood pressure: systolic, diastolic and mean pressure s and controller Brings and/or sidestream Invasive blood pressure. Systems, main and/or sidestream FIO2 lt will extend the functionality of the existing Argus PB-1000 system (K0122Z6). The function and the promoter her PB-1000 and the visualisation unit AR It will extend the functionality of the existing Algust PB-1000 (PB-100) (PB-100) The system comprises the parameter box PB-1000 and the visualisation unit ARGUS (PBS) and th The system compilses the parcined via a serial interface. PRO. The two units are connected via a serial intenated and calculated in the PB-2200. This All vital parameters and evaluations are registered and calouaced manager generally used data is then transmitted to the visualisation unit ARGUS PRO or another generally us data is then transmitted to the visuallsation und monitored on the ARGUS PRO. PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. PC via the serial interface. All data can be snown and monecessed power input (RS The PB-2200 is operated using an internal battery and an external power input (RS e and the The PB-2200 is operated using an internal battery alle an and the manate from the 232/12V), which is, like the data transmission, completely sop visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V. The system is intended for use in the intensive care unit, in the recovery room, in the The system is intended for ass internal transports.
    Device Description
    The system comprises the Parameter Box PB-1000 and the Visualisation Unit AR-GUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.
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