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510(k) Data Aggregation
K Number
K152585Device Name
Resmon PRO FULL
Manufacturer
MEDICAL GRAPHICS CORP.
Date Cleared
2016-06-24
(288 days)
Product Code
PNV, BZC
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL GRAPHICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Resmon PRO FULL is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Resmon PRO FULL is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics. and private physician offices.
Device Description
Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT).
FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system.
FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device.
Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.
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K Number
K070858Device Name
EXPRESS SERIES
Manufacturer
MEDICAL GRAPHICS CORP.
Date Cleared
2007-04-16
(19 days)
Product Code
BZL
Regulation Number
868.1730Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL GRAPHICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.
The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Device Description
The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.
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K Number
K061731Device Name
MEDGRAPHICS ULTIMA SYSTEM
Manufacturer
MEDICAL GRAPHICS CORP.
Date Cleared
2006-09-06
(78 days)
Product Code
BZL
Regulation Number
868.1730Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL GRAPHICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultima system uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.
The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Device Description
The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.
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K Number
K955432Device Name
CPX, CCM, CATH WITH 15% CO2
Manufacturer
MEDICAL GRAPHICS CORP.
Date Cleared
1996-07-01
(216 days)
Product Code
BZM
Regulation Number
868.1900Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL GRAPHICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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