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FDA 510(k)

SMOOTH-FLO CIRCUIT

K-Number: K010402 · 2001-03-14

ApplicantHudson Respiratory Care, Inc.
Decision Date2001-03-14
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMOOTH-FLO CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Respiratory Care, Inc.. It received FDA 510(k) clearance on 2001-03-14 under 510(k) number K010402. 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 SMOOTH-FLO CIRCUIT?

SMOOTH-FLO CIRCUIT is a medical device that received FDA 510(k) clearance on 2001-03-14. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K010402.

When did SMOOTH-FLO CIRCUIT receive FDA 510(k) clearance?

SMOOTH-FLO CIRCUIT received FDA 510(k) clearance on 2001-03-14, under 510(k) number K010402.

Who is the listed applicant for SMOOTH-FLO CIRCUIT?

The FDA 510(k) record lists Hudson Respiratory Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMOOTH-FLO CIRCUIT?

The FDA product code for SMOOTH-FLO CIRCUIT is BTT.

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Other records listing Hudson Respiratory Care, Inc. as applicant

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.

K031383MODEL 780K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIK011134OXYGEN SUPPLY TUBING, MODEL 1115K001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896

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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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