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K Number
K002881
Device Name
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
Manufacturer
PULMONETIC SYSTEMS, INC.
Date Cleared
2000-10-11

(26 days)

Product Code
CBK
Regulation Number
868.5895
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).