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510(k) Data Aggregation

    K Number
    K103575
    Device Name
    SPIRO PD
    Manufacturer
    Date Cleared
    2011-11-09

    (338 days)

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

    PMD HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: - 2-12 years Child - 13-21 years Adolescent - 22 and over- Adult
    Device Description
    The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical signals must be changed to electrical signals. The devices responsible for this change are called transducers. The SPIRO PD has a Turbine-type transducer. The turbine transducer performs transduction in two stages: The volume to be measured crosses the turbine vane and records its rotation that is proportional to that Volume, this rotation is detected by the interrupting of a beam of infrared light, the sensor of which converts the light received into a digital-type electrical signal. The SPIRO PD performs the following tests: - FVC, - FEV1 . - FEV1/FVC ● - PEF - FEF 25-75% - Estimated Lung Age and Flow/Volume Curve . The Spiro PD performs the following calculations: - % Predicted of FVC ● - Severity of FVC . - % Predicted of FEV1 - Severity of FEV1 . - % Predicted of FEV1/FVC . - Severity of FEV1/FVC . - % Predicted of FEF 25-75% . - Severity of FEF 25-75% - % Predicted of PEF, Severity of PEF . The physical configuration of the Spiro PD: - Display Color, Touch screen LCD 320 x 240 resolution . - Keyboard - Touch screen - Power supply 3.7V Lithium-ion battery 650 mAh . - Dimensions 200 x 96 x 40mm . - Weight 256g with battery .
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