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K Number
K960795
Device Name
VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE
Manufacturer
VYGON CORP.
Date Cleared
1996-05-22

(85 days)

Product Code
BTR
Regulation Number
868.5730
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).