LogoFDA 510(k) Search
K Number
K011125
Device Name
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
Manufacturer
HUDSON RESPIRATORY CARE, INC.
Date Cleared
2001-06-13

(61 days)

Product Code
CAT
Regulation Number
868.5340
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5340 Nasal oxygen cannula.

(a)
Identification. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.(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.