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FDA 510(k)

THE INCOURAGE SYSTEM

K-Number: K051383 · 2005-06-17

ApplicantRespiratory Technologies, Incorporated
Decision Date2005-06-17
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE INCOURAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Technologies, Incorporated. It received FDA 510(k) clearance on 2005-06-17 under 510(k) number K051383. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE INCOURAGE SYSTEM?

THE INCOURAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-17. The listed applicant is Respiratory Technologies, Incorporated. The 510(k) number is K051383.

When did THE INCOURAGE SYSTEM receive FDA 510(k) clearance?

THE INCOURAGE SYSTEM received FDA 510(k) clearance on 2005-06-17, under 510(k) number K051383.

Who is the listed applicant for THE INCOURAGE SYSTEM?

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

What is the FDA product code for THE INCOURAGE SYSTEM?

The FDA product code for THE INCOURAGE SYSTEM is BYI.

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Related Devices (Code: BYI)

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.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, Inc.

Official Source

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

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