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510(k) Data Aggregation

    K Number
    K961779
    Device Name
    MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
    Date Cleared
    1997-06-13

    (401 days)

    Product Code
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVION MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Measures Peak Expiratory Flow Rate (PEFR) for people who have respiratory conditions such as asthma.
    Device Description
    Mini-Bell Peak Flow Meter/Low Range Model Peak Flow Meter
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