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510(k) Data Aggregation

    K Number
    K001528
    Device Name
    PC FLOW +
    Date Cleared
    2001-01-18

    (246 days)

    Product Code
    Regulation Number
    868.1840
    Why 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
    K982956
    Device Name
    FLOWMATE II PLUS, MODEL #4000
    Date Cleared
    1998-11-24

    (92 days)

    Product Code
    Regulation Number
    868.1840
    Why 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
    K954759
    Device Name
    FLOWMATE LTE
    Date Cleared
    1996-04-12

    (178 days)

    Product Code
    Regulation Number
    868.1840
    Why 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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