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510(k) Data Aggregation

    K Number
    K013812
    Device Name
    SPIROLAB II, MODEL 29
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2002-02-11

    (88 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K061571
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or trained technician to measure lung function in patients of all ages. It can be used in any setting, home, factory, hospital or physician's office.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the SDI Spirolab II Spirometer. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

    Therefore, I cannot answer your request based on the provided text.

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