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510(k) Data Aggregation

    K Number
    K132168
    Device Name
    BRONCHOSCOPY ELBOW
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2013-11-20

    (131 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRONCHOSCOPY ELBOW

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

    The Bronchoscopy Elbow can be used with Respironics Masks that incorporate the mating elbow hub design. Use of this elbow with these masks allows CPAP and bi-level the patient during a bronchoscopy procedure. The elbow is for single use in the hospital/institutional environment only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Bronchoscopy Elbow." This type of document does not contain information about the acceptance criteria or the study that proves the device meets them. It primarily addresses the regulatory aspects of the device and its substantial equivalence to a predicate device.

    Therefore, I cannot answer your request based on the given input, as the information you are asking for is not present in this document.

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