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FDA 510(k)

OXYGEN SUPPLY TUBING, MODEL 1115

K-Number: K011134 · 2001-06-13

ApplicantHudson Respiratory Care, Inc.
Decision Date2001-06-13
Product CodeBYX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN SUPPLY TUBING, MODEL 1115 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 2001-06-13 under 510(k) number K011134. The device is classified under product code BYX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN SUPPLY TUBING, MODEL 1115?

OXYGEN SUPPLY TUBING, MODEL 1115 is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Hudson Respiratory Care, Inc.. The 510(k) number is K011134.

When did OXYGEN SUPPLY TUBING, MODEL 1115 receive FDA 510(k) clearance?

OXYGEN SUPPLY TUBING, MODEL 1115 received FDA 510(k) clearance on 2001-06-13, under 510(k) number K011134.

Who is the listed applicant for OXYGEN SUPPLY TUBING, MODEL 1115?

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 OXYGEN SUPPLY TUBING, MODEL 1115?

The FDA product code for OXYGEN SUPPLY TUBING, MODEL 1115 is BYX.

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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 HRCIK010402SMOOTH-FLO CIRCUITK001213CONCHATHERM 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: BYX)

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.

K955656NORTH STATE PLASTICS AEROSOL TEENorth State Plastics, Inc.K943110GAS SAMPLING INTERFACESCoast Medical, Inc.K935835BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIESBusse Hospital Disposables, Inc.K931043MF OHMEDA STYLE MEDICAL GAS WALL OUTLETSMedical Fittings, Inc.K931033MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETSMedical Fittings, Inc.K913422OXYGEN TUBING, 81503Specialty Packaging Producs, Inc.

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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