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510(k) Data Aggregation
K Number
K001528Device Name
PC FLOW +
Manufacturer
Date Cleared
2001-01-18
(246 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
SPIROMETRICS MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K982956Device Name
FLOWMATE II PLUS, MODEL #4000
Manufacturer
Date Cleared
1998-11-24
(92 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
SPIROMETRICS MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended use for the Flowmate II PLUS is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the effort and then reported as numerical results with a printout of the results if selected.
Indications For Use: Pulmonary Function Testing
Diagnostic
To evaluate symptoms, signs, or abnormal laboratory tests
- Symptoms: dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain
- Signs: diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest deformity, unexplained crackles
- Abnormal laboratory tests: hypoxemia, hypercapnia, polycythemia, abnormal chest radiographs
To measure the effects of disease on pulmonary function
To screen individuals at risk of having pulmonary diseases
- Smokers
- Individuals in occupations with exposures to injurious substances
- Some routine physical examinations
- To assess preoperative risk
- To assess prognosis (lung transplant, etc.)
- To assess health status before enrollment in strenuous phsical activity programs
Monitoring
To assess therapeutic interventions
- Bronchodilator therapy
- Steroid treatment for asthma, interstitial lung disease, etc.
- Management of congestive heart failure
- Other (antibiotics in cystic fibrosis, etc.)
- To describe the course of diseases affecting lung function
- Pulmonary diseases
- Obstructive airways diseases
- Interstitial lung diseases
- Cardiac diseases
Congestive heart failure
- Neuromuscular diseases
Guillain-Barré
To monitor persons in occupations with exposure to injurious agents
To monitor for adverse reactions to drugs with known pulmonary toxicity
Disability / Impairment Evaluations
To assess patients as part of a rehabilitation program
- Medical
- Industrial
- Vocational
To assess risks as part of an insurance evaluation
To assess individuals for legal reasons
- Social Security or other government compensation programs
- Personal injury lawsuits
- Others
Public Health
Epidemiologic surveys
- Comparison of health status of populations living in different environments
- Validation of subjective complaints in occupational / environmental settings Derivation of reference equations
Device Description
Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate LTE, Flowmate, and PC Flow + devices)
Desktop design molded from high impact UL rated ABS plastic
Automatic calculations of test results, and best test selection based on American Thoracic Society (ATS) criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
Population Predicted Normals included: Composite Knudson - 1976 Knudson - 1983 Crapo (ITS) ECCS Hsu Lam
Customization allows user to change report format, input temperature and barometric readings, and select internal / external printer and associated driver for printer selected
Reports printed on thermal paper 112mm wide or standard 8 1/2 " x 11" paper
Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system
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K Number
K954759Device Name
FLOWMATE LTE
Manufacturer
Date Cleared
1996-04-12
(178 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
SPIROMETRICS MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended use for the Flowmate LTE is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the entire effort and then reported as numerical results with a printout of the effort if selected.
Device Description
Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate, PC Flow +, Renaissance, and Flash devices)
Compact design molded from high impact UL rated ABS plastic. rechargeable Ni-Cad batteries for portable operation,
Automatic calculations of test results, and best test selection based on ATS criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
Population Predicted Normals included: Composite Knudson Crapo (ITS) ECCS HSU
Customization allows user to change report format, input temperature and barometric readings, and select printer driver for printer being used
Reports printed on standard 8 1/2 " x 11" paper
Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system
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Ask a specific question about this device
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