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510(k) Data Aggregation

    K Number
    K970445
    Device Name
    VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300
    Date Cleared
    1998-01-30

    (359 days)

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

    PACE TECH MEDICAL MONITORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vitalmax 4000 is intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), SpO2 waveform, Pulse (SpO2 and NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate. The Vitalmax 4100 CN is intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), Sp02 waveform, Pulse (SpO2 and NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate, Nitrous oxide concentration (N2O). The Vitalmax 4100 G and Vitalmax 4100 A include these additional parameters: End-tidal expired Halothane, Enflurane agent-gas concentration (etHAL, etENF. etISO), Inspired Halothane, Enflurane, or Isoflurane agent gas concentration (inHAL. inENF, inISO), Fractional inspired oxygen in gas concentration (Fio2 or %o2). The Minipack 3000 and Minipack 3100 are intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), SpO2 waveform, Pulse (SpO2 and NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate. The Minipack 300 and Vitalmax 800 PLUS are intended for use in the hospital/clinical environment to measure and monitor the following parameters: ECG waveform, NIBP systolic, diastolic, and mean arterial pressure values (MEAN or MAP), Blood oxygen saturation (SpO2 or Pulse oximetry), SpO2 waveform, Pulse (SpO2 or NIBP) signal strength, Pulse (SpO2 and NIBP) or heart (ECG) rate, Temperature, End-tidal Co2 concentration (Et Co2), Co2 waveform, Minimum inspired Co2 concentration (inCo2), Respiration rate. None of the devices are intended to be used as apnea monitor or during MRI (Magnetic Resonance Imaging).
    Device Description
    The Vitalmax 4000 is available in configured and modular form. The Vitalmax 4000 configured monitor is available in various models which offer the options of Co2, thoracic impedance respiration, printer, and invasive pressures. Additional options offered are: Built-in printer with two channels of annotated waveform or text form of vital signs, Thoracic impedance respiration, Invasive pressure waveforms: systolic, diastolic, and mean values (IP, IP2), Second temperature channel and A temp, Analog output. The Vitalmax 4100 CN, Vitalmax 4100 G, and Vitalmax 4100 A are described with various parameters they measure and monitor. Additional options offered for both models are: Thoracic impedance respiration, Invasive pressure waveform, systolic, diastolic and mean values (IP1, IP2), Second temperature channel and teperature difference [A temp], Built-in strip chart recorder, Sevoflurane, and Desflurane (etSev, inSev, etDes, inDes), Analog Output. The Minipack 3000 and Minipack 3100 are described with various parameters they measure and monitor. Additional options offered are: Built-in printer with two channels of annotated waveform or text form of vital signs, Thoracic impedance respiration, Invasive pressure waveforms: systolic, diastolic, and mean values (IP1, IP2), Second temperature channel and A temp, Analog output. The Minipack 300 and Vitalmax 800 PLUS are described with various parameters they measure and monitor. Additional options offered are: Thoracic impedance respiration, Add-on 27 ccolumn thermal printer (Minipack 300 Series), Built-in printer with two channels of annotated waveform (Vitalmax 800 PLUS), Analog output.
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