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K Number
K040726
Device Name
VENTLAB NASAL CPAP CANNULA
Manufacturer
VENTLAB CORP.
Date Cleared
2004-06-03

(73 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

The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive airway pressure therapy (i.e., CPAP, BiLevel).

Device Description

Ventlab Nasal CPAP Cannula

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Nasal CPAP Cannula." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or details about any studies conducted (like MRMC or standalone studies).

Therefore, I cannot fulfill your request for this information from the provided document. The document primarily focuses on the regulatory clearance process and includes an "Indications for Use" statement, but no technical study details.

§ 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).