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510(k) Data Aggregation
K Number
K192488Device Name
CO2 Sidestream Module
Manufacturer
Beijing Kingst Commercial & Trade Co.,Ltd.
Date Cleared
2020-05-22
(254 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
**Beijing Kingst Commercial **& Trade Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.
Device Description
The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control. The operation of the CO2 Sidestream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the Module's memory. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for the calculation for the concentrations of carbon dioxide, which improves the design accuracy. The Module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). Respiration rate is calculated by measuring the time interval between detected breaths.
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K Number
K192446Device Name
CO2 Mainstream Module
Manufacturer
Beijing Kingst Commercial & Trade Co.,Ltd.
Date Cleared
2020-05-21
(258 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
**Beijing Kingst Commercial **& Trade Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery, in Emergency Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a monitoring system during anesthesia/recovery in host Emergencv Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Device Description
The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.
The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module'smemory.
The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy.
The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.
The differences between the Capno M and M+ are only with the intended patient type. The Capno M is intended for use on intubated patients, where the Capno M+ is intended for use with intubated and non-intubated patients. The operating principles, unit of measurement, ETCO2 measurement range, accuracy, respiration rate range, and respiration rate accuracy are the same for both devices.
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