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510(k) Data Aggregation

    K Number
    K061283
    Device Name
    PULMOLIFE
    Manufacturer
    MICRO MEDICAL, LTD.
    Date Cleared
    2006-12-14

    (220 days)

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

    MICRO MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device measures the exhaled breath of a patient, specifically FEV1. The results can be used for the diagnosis of COPD in adult smokers. The device measures expiratory lung function parameters, specifically FEV1 and conforms to ATS standards for diagnostic devices. The results obtained can be used for screening of COPD in adult smokers.
    Device Description
    The PulmoLife is a battery operated hand held portable spirometer. It uses a uni-directional, rotating vane, flow sensing turbine to measure lung function parameters, specifically Forced Expiratory Volume in the 1st second of expiration (FEV1) and FEV1 as a percentage of the predicted value (FEV1 %predicted). Lung age estimation is also given. It is supplied with one way valve safety mouthpieces, carrying pouch and instruction manual.
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