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510(k) Data Aggregation

    K Number
    K173770
    Device Name
    OJR215 Pressure Relief Manifold
    Manufacturer
    Fisher & Paykel Healthcare Limited
    Date Cleared
    2019-04-05

    (480 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OJR215 Pressure Relief Manifold

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

    The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula.

    The device is intended for use with flow rates greater than 0.5 L/min up to, and including. 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but I cannot answer the question with the provided context. The document is an FDA 510(k) clearance letter and Indications for Use statement for a medical device called the "OJR215 Pressure Relief Manifold." This document explains the device's intended use and regulatory classification but does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself or related study reports, which are not part of this document.

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