FDA 510(k)

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula

Numéro K : K240163 · 2024-09-27

Date de décision2024-09-27

Code produitBTT

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K240163. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula?

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Medline Industries, LP. The 510(k) number is K240163.

When did Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula receive FDA 510(k) clearance?

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula received FDA 510(k) clearance on 2024-09-27, under 510(k) number K240163.

Who is the listed applicant for Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula?

The FDA product code for Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula is BTT.

Essais cliniques associés

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Dispositifs connexes (Code : BTT)

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

Source officielle

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