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K Number
K982530
Device Name
SULLIVAN MIRAGE FULL FACE MASK
Manufacturer
RESMED LTD.
Date Cleared
1998-10-16

(88 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 Sullivan® Mirage™ Full Face Mask is a patient interface accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.

Device Description

Sullivan® Mirage™ Full Face Mask System

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Sullivan® Mirage™ Full Face Mask System). This document does not contain any information regarding acceptance criteria, study details, or performance metrics for the device.

Therefore, I cannot provide the requested table and information about a study based on this input. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

§ 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).