Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K983366
    Device Name
    TRIP TONOMETRY CATHETER, 16F
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-12-23

    (90 days)

    Product Code
    KNT, CBR, CCK
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trip® Tonometry Catheter, 16 F (with stopcock) is used for the determination of regional PCO2 (PrCO>) and intramucosal pH (pHi) of the gastric mucosal tissue. This catheter is also used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter (which are separate from the device) serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer protector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach. The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia The Trip® Tonometry Catheter, 16 F (with biofilter and sampling line) is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer profector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach. The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia
    Device Description
    Not Found
    Ask a Question
    K Number
    K982091
    Device Name
    CS/3 COMPACT AIRWAY MODULE, M-COVX
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-12-22

    (190 days)

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

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For monitoring hospital patient's respiration (CO2, O2, N2O and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon (an way production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The system is intended for use by qualified medical personnel only.
    Device Description
    Not Found
    Ask a Question
    K Number
    K981378
    Device Name
    DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-11-03

    (201 days)

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

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient's ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case.
    Device Description
    Not Found
    Ask a Question
    K Number
    K973985
    Device Name
    AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-10-30

    (375 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for The A.J. > Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. The AS/3™ ADU is indicated for all persons that require inhalation anesthesia. The AS/3™ ADU shall be operated by qualified anesthesia personnel.
    Device Description
    AS/3™ Anaesthesia Delivery Unit (AS/3TM ADU) is an Anesthesia Gas Machine.
    Ask a Question
    K Number
    K980362
    Device Name
    MRI COMPATIBLE MONITOR AND ACCESSORIES
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-06-30

    (152 days)

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

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Datex-Engstrom MRI Patient Monitor and accessories is indicated for monitoring of ECG waveform for Heart Rate and Asystole detection, SpO22, Non-invasive blood pressure (NIBP), airway gases, anesthetic agents, airway flow, airway pressure and airway volume on patients during MR imaging. It is indicated for use inside the MRI room mounted outside the 20 Gauss line and with magnets of field strength 1.5 Tesla or less. SpO2monitoring is indicated only with the use of Datex-Engstrom sensors specifically designed for use in the MRI environment. ECG monitoring is indicated only with use of the MRI ECG lead set.
    Device Description
    MRI Patient Monitor and Accessories
    Ask a Question
    K Number
    K974792
    Device Name
    CS/3(TM) MONITORS*
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-06-02

    (162 days)

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

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CS/3TMMonitors are indicated for multiparameter patient monitoring in all hospital patients.
    Device Description
    CS/3™ Monitors* * Includes CS/3™ Critical Care Monitor and CS/3™ Compact Monitor.
    Ask a Question
    K Number
    K980384
    Device Name
    TRIP TONOMETRY CATHETER, 18F
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-05-01

    (88 days)

    Product Code
    CCK, CBR, KNT
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRIP Tonometry Catheter, 18F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter built into the device serve as a means of connecting the catheter to the TONOCAP™ monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. Since it incorporates a vented gastric sump it is also used for feeding and/or decompression or aspiration of the contents of the stomach. It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency / trauma patients and hospital patients with suspected mesenteric ischemia.
    Device Description
    Not Found
    Ask a Question
    K Number
    K974747
    Device Name
    CS/3 ARRHYTHMIA WORKSTATION
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-04-23

    (125 days)

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

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.
    Device Description
    Not Found
    Ask a Question
    K Number
    K974101
    Device Name
    DATEX-ENGSTROM NETWORK
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-02-06

    (99 days)

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

    DATEX-ENGSTROM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices. The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS). The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1