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K Number
K965132

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Device Name
HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
Manufacturer
MALLINCKRODT MEDICAL
Date Cleared
1997-03-20

(87 days)

Product Code
BTR
Regulation Number
868.5730
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K030570,K081086,K082520,K090352,K091761,K111401,K223130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).