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510(k) Data Aggregation

    K Number
    K251572

    Validate with FDA (Live)

    Device Name
    eRapid with eTrack System
    Manufacturer
    Pari Respiratory Equipment, Inc.
    Date Cleared
    2025-12-19

    (211 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    4 - 120
    Reference & Predicate Devices
    K201167,K223840
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The eRapid Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

    Device Description

    The eRapid with eTrack controller is a single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. It is for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

    AI/ML Overview

    N/A

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