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K Number
K002288
Device Name
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
Manufacturer
COOK, INC.
Date Cleared
2000-11-28

(124 days)

Product Code
CBI
Regulation Number
868.5740
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).