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FDA 510(k)

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

K-Number: K220565 · 2022-10-25

ApplicantMedline Industries, Inc.
Decision Date2022-10-25
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-10-25 under approval number K220565. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is a medical device that received FDA 510(k) clearance on 2022-10-25. It is manufactured by Medline Industries, Inc.. The 510(k) number is K220565.

When was Hudson RCI Triflo II Incentive Deep Breathing Exerciser approved by the FDA?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser received FDA 510(k) clearance on 2022-10-25, under approval number K220565.

What company makes Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

Hudson RCI Triflo II Incentive Deep Breathing Exerciser is manufactured by Medline Industries, Inc..

What is the FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

The FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser is BWF.

Related Clinical Trials

NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT07435532 Comparative Effects of Breather Device and Incentive Spirometer in Patients With COPD NOT_YET_RECRUITING NCT07544433 Diaphragmatic Training on GERD RECRUITING NCT06688422 Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy RECRUITING

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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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