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510(k) Data Aggregation

    K Number
    K022636
    Device Name
    BODY BOX 5500
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2003-01-13

    (158 days)

    Product Code
    JEH
    Regulation Number
    868.1760
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BODY BOX 5500

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

    The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Body Box 5500" device. It does not contain the specific information needed to answer the request about acceptance criteria and a study proving a device meets them. The letter confirms substantial equivalence to a predicate device but does not detail performance metrics, study design, or results.

    Therefore, I cannot provide the requested information based on the provided text.

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