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K Number
K000994
Device Name
BIPAP DUET LX BI-LEVEL SYSTEM
Manufacturer
RESPIRONICS, INC.
Date Cleared
2000-06-22

(86 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
Device Description
AI/ML Overview

§ 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).