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510(k) Data Aggregation
K Number
K040917Device Name
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
Manufacturer
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
Date Cleared
2004-04-29
(21 days)
Product Code
CBQ, CBS
Regulation Number
868.1500Why did this record match?
Product Code :
CBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas and to provide this data to health care contents in the volunation varially varialy via the Component Monitoring System, for the support of clinical decision making.
The device is indicated for use in health care facilities by health care professionals whenever The device is intriculour of assiric and neonate patient anesthesia gas monitoring.
Device Description
The name of this device is the PhilipsM1026B Anesthetic Gas Monitor for use with the Philips IntelliVue Family of Patient Monitors MP40/50/60/70/90, the Anesthesia Component Monitoring System M1176A and the Philips Viridia 24 System. The common name is the Philips Anesthesia Gas Monitor.
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K Number
K994188Device Name
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
Manufacturer
AGILENT TECHNOLOGIES, GMBH
Date Cleared
2000-05-19
(158 days)
Product Code
CBQ, CBS
Regulation Number
868.1500Why did this record match?
Product Code :
CBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M1026A Anesthesia gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making.
The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.
Device Description
The above device operates with Agilent Technologies Anesthesia Component Monitoring System (ACMS) and the Viridia 24 Agilent Technologies Model 1204A through a digital interface (RS232). The monitoring system is known as the Model M1166A Component Monitoring System (CMS). When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients. The device will signal physiological alarms and document deviations when preset limits are exceeded. An INOP ("inoperative") alarm is triggered and a message is displayed in the event of malfunction, lack of detectable breath, power disconnects, and other inoperative states.
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K Number
K962648Device Name
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
Manufacturer
OHMEDA MEDICAL
Date Cleared
1997-01-17
(193 days)
Product Code
CBQ
Regulation Number
868.1500Why did this record match?
Product Code :
CBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ohmeda Model 5330 Anesthetic Agent Monitor is intended for general hospital or clinical use by medical professionals whenever it is desired to monitor concentrations of anesthetic gas. The agents monitored include isoflurane, endoflurane, halothane, desflurane and sevoflurane. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. It is available for sale only by or on the order of a licensed medical practitioner
Device Description
The Ohmeda Model 5330 Anesthetic Agent Monitor is a benchtop instrument which draws a continuous flow of sample gas from a patient's anesthesia circuit. The sample is then drawn through a measurement chamber where agent concentration is measured. Measured values are displayed as numbers and as a graph on the illuminated display panel on the front of the unit is operated by push buttons on the front panel . The major functional subsystems of the device are the power supply, the pneumatic system, the measurement chamber, the electronics and the software. Power is supplied by a power cord connected to the AC line. There is no internal battery. AC power is conditioned internally by the power supply subassembly. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the measurement chamber, which is a cavity within the optical bench assembly. The sample is then exhausted out the back of the unit. The measurement cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of absorption. The infrared light source consists of a coiled resistive metal element which radiates a relatively wide spectrum of infrared. Two infrared optical filters rotate on a wheel in the optical path, providing alternating wavelengths of illumination through the sample. The amount of transmitted infrared light is measured with an optical detector. By using the detected levels of transmitted infrared light at the two alternating wavelengths, anesthetic agent concentrations can be calculated. The electronic system consists of an analog circuit board and a digital circuit board . The analog board takes electrical signals from the measurement chamber and conditions them so measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agent in the sample gas.
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