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FDA 510(k)

COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA

K-Number: K061736 · 2006-08-18

ApplicantTeleflex Medical
Decision Date2006-08-18
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2006-08-18 under 510(k) number K061736. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA?

COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Teleflex Medical. The 510(k) number is K061736.

When did COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA receive FDA 510(k) clearance?

COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA received FDA 510(k) clearance on 2006-08-18, under 510(k) number K061736.

Who is the listed applicant for COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA?

The FDA 510(k) record lists Teleflex Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA?

The FDA product code for COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA is BTT.

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Related Devices (Code: BTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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