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510(k) Data Aggregation
K Number
K130170Device Name
EXSPIRON 1XI
Manufacturer
RESPIRATORY MOTION, INC.
Date Cleared
2013-05-29
(125 days)
Product Code
BZK, BZQ
Regulation Number
868.1850Why did this record match?
Applicant Name (Manufacturer) :
RESPIRATORY MOTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients.
ExSpiron 1xi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
Tidal volume,
Respiratory rate, and
Minute ventilation
ExSpiron 1xi measurements are used as an adjunct to other clinical information sources.
Device Description
The ExSpiron 1xi system consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Computer: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrode assembly containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode PadSet is also used to perform subsystem checks prior to patient measurements.
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K Number
K120087Device Name
EXSPIRON
Manufacturer
RESPIRATORY MOTION, INC.
Date Cleared
2012-09-26
(259 days)
Product Code
BZK, BZQ
Regulation Number
868.1850Why did this record match?
Applicant Name (Manufacturer) :
RESPIRATORY MOTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ExSpiron is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients.
ExSpiron is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
- Tidal volume, .
- . Respiratory rate, and
- Minute ventilation. ●
ExSpiron measurements are used as an adjunct to other clinical information sources.
Device Description
The ExSpiron™ consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Panel PC: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead set containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode lead set is also used to perform subsystem checks prior to patient measurements.
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