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510(k) Data Aggregation

    K Number
    K970507
    Device Name
    PEAK FLOW METER
    Manufacturer
    INTL. MEDICAL, INC.
    Date Cleared
    1997-06-13

    (123 days)

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

    INTL. MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use.
    Device Description
    IMI Peak Flow Meter
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