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510(k) Data Aggregation

    K Number
    K992722
    Device Name
    PRIMEAIRE
    Manufacturer
    THAYER MEDICAL CORP.
    Date Cleared
    1999-11-10

    (89 days)

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

    PRIMEAIRE

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

    The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,

    Device Description

    The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use.

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding the "PrimeAire" device. It is a letter confirming that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter, not a performance study report.

    Therefore, I cannot provide the requested information based on the input.

    To answer your request, I would need a document that describes the design verification and validation testing for the PrimeAire device, including its performance characteristics and the studies conducted to demonstrate its safety and effectiveness.

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