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510(k) Data Aggregation

    K Number
    K973456
    Device Name
    SPIROBANK PORTABLE PC BASED SPIROMETER
    Date Cleared
    1998-07-22

    (314 days)

    Product Code
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTUREMED AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations. The tests can be performed in adults and pediatrics, in the hospital, clinic and at home. Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.
    Device Description
    Not Found
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    K Number
    K953948
    Device Name
    SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
    Date Cleared
    1996-06-25

    (314 days)

    Product Code
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUTUREMED AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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