LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970959
    Device Name
    INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    1997-06-13

    (88 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K970459
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    On/Off control of oxygen flow when using a resuscitator bag. For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.

    Device Description

    Instant Flow Valves

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Instant Flow Valves" and an "Indication for Use Statement". It does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance), or training set information for a medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely a regulatory clearance for marketing based on substantial equivalence to a predicate device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1