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510(k) Data Aggregation

    K Number
    K961779

    Validate with FDA (Live)

    Device Name
    MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
    Manufacturer
    AVION MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-06-13

    (401 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Mini-Bell Peak Flow Meter. It primarily focuses on regulatory approval and does NOT contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot extract the requested information from this document.

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