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K Number
K955238
Device Name
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
Manufacturer
RUSCH INTL.
Date Cleared
1996-02-06

(84 days)

Product Code
BSR
Regulation Number
868.5790
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5790 Tracheal tube stylet.

(a)
Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.