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K Number
K993307
Device Name
ARIA LX CPAP SYSTEM
Manufacturer
RESPIRONICS, INC.
Date Cleared
1999-10-27

(23 days)

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

Not Found

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter. It states that marketing of the device is permitted but does not contain any information about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes.

Therefore, I cannot answer your request based on the input provided. The letter is a regulatory document confirming substantial equivalence, not a summary of the underlying technical and clinical studies.

§ 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).