LNZ · Changer, Tube, Endotracheal

Anesthesiology · 21 CFR 868.5730 · Class 2

Overview

Product CodeLNZ
Device NameChanger, Tube, Endotracheal
Regulation21 CFR 868.5730
Device ClassClass 2
Review PanelAnesthesiology
3rd-Party ReviewableYes

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.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (2 of 2)

RecordDevice NameApplicantDecision DateDecision
K102127ENDOTRACHEAL TUBE CHANGERSInstrumentation Industries, Inc.Aug 27, 2010SESE
P800068ENDOTRACHEAL TUBE CHANGERInstrumentation Industries, Inc.Jul 21, 1981APRL

Top Applicants

Innolitics

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