LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021443
    Device Name
    56 SERIES JET NEBULIZER
    Manufacturer
    PROJECT MARKETING
    Date Cleared
    2002-10-21

    (168 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Abbreviated
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    56 SERIES JET NEBULIZER

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

    The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.

    Device Description

    The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a medical device: the "56 Series Jet Nebulizer". This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with detailing the results of a primary clinical study that establishes novel performance criteria for an AI or imaging device.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance for an AI/imaging device cannot be extracted from this document.

    This document primarily confirms that the device has been reviewed and found substantially equivalent to existing devices, allowing it to be marketed. It does not contain the kind of performance data or study design details that would be required to answer your specific questions, which are typically relevant for AI/imaging device submissions.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1