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K Number
K071689
Device Name
DEVILBISS INTELLIPAP MODEL DV 5 SERIES
Manufacturer
SUNRISE MEDICAL
Date Cleared
2007-09-07

(79 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 DeVilbiss IntelliPAP Model DV5 Series is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the DeVilbiss IntelliPAP Model DV5 Series. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device for treating obstructive sleep apnea.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) from the provided text.

§ 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).