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510(k) Data Aggregation

    K Number
    K971889
    Device Name
    CHAD TOTAL O2 DELIVERY SYSTEM
    Manufacturer
    CHAD THERAPEUTICS, INC.
    Date Cleared
    1997-11-17

    (180 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHAD TOTAL O2 DELIVERY SYSTEM

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

    The TOTAL O,TM Delivery System is indicated for Supplemental Medical Oxygen for treatment of Respiratory Diseases.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Chad TOTAL O2™ Delivery System. It primarily addresses the regulatory approval of the device and does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance.

    The letter only includes:

    • Device Name: Chad TOTAL O2™ Delivery System
    • Indication for Use: "Supplemental Medical Oxygen for treatment of Respiratory Diseases."
    • Regulatory Class: II
    • Product Code: 73 CAW
    • 510(k) Number: K971889

    To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification/validation report, or the actual study report submitted to the FDA for review. These documents typically contain the detailed information about performance criteria, study design, sample sizes, and ground truth establishment.

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