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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
AN
Reference & Predicate Devices
N/A
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.

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).