LogoFDA 510(k) Search
K Number
K022650
Device Name
APEX MEDICAL CPAP RT 21XX
Manufacturer
APEX MEDICAL CORP.
Date Cleared
2004-02-04

(544 days)

Product Code
BZD
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA).

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a CPAP device. This document does not contain information regarding acceptance criteria, device performance, study methodologies (such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance), or details about ground truth establishment for any machine learning or AI models.

Therefore, I cannot fulfill your request for this information based on the input document.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).