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510(k) Data Aggregation

    K Number
    K984468
    Device Name
    VITAL PEP
    Manufacturer
    VITAL SIGNS, INC.
    Date Cleared
    1999-06-01

    (167 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vital PEP™ positive expiratory pressure device indicated for facilitating the opening of airways in patients suffering from COPD , Cystic Fibrosis, Asthma and other diseases with ... coretory groblems.

    Device Description

    Vital PEP™ positive expiratory pressure device

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the Vital PEP™ device and does not contain information about acceptance criteria or a study proving the device meets them.

    Therefore, I cannot answer your request based on the provided input. This document simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices and can proceed to market. It does not include performance data, study designs, or ground truth establishment details.

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