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K Number
K980721
Device Name
SULLIVAN AUTOSET
Manufacturer
RESMED LTD.
Date Cleared
1998-09-01

(189 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

Treatment of obstructive sleep apnea in adult patients.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "Sullivan AutoSet Nasal CPAP System" (K980721). It states that the device is substantially equivalent to legally marketed predicate devices for the "Treatment of obstructive sleep apnea in adult patients."

However, this document does not include information on acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of information are typically found in the 510(k) submission document itself, not in the clearance letter.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input.

§ 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).