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510(k) Data Aggregation

    K Number
    K965042
    Device Name
    MICRODL DIARYCARD SPIROMETER
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1997-06-17

    (182 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K963035
    Why did this record match?
    Device Name :

    MICRODL DIARYCARD SPIROMETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To measure lung functions - FEV 1 , FVC, and PEF and to effect historical serial transfer of measured test indices to PC compatible computers

    Device Description

    A hand-held portable electronic spirometer measuring FEV1, FVC, and PEF.

    AI/ML Overview

    The provided document is a 510(k) summary for the MicroDL DiaryCard Spirometer. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states "Performance Testing: None applicable" in the comparison table and includes no dedicated section on performance criteria or a study demonstrating the device meets those criteria.

    Therefore, based on the provided text, it's not possible to extract the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present. The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance study results.

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