Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hudson RCI® TurboMist™ Nebulizer System

K-Number: K230602 · 2023-10-31

ApplicantMedline Industries, LP
Decision Date2023-10-31
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI® TurboMist™ Nebulizer System is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2023-10-31 under approval number K230602. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI® TurboMist™ Nebulizer System?

Hudson RCI® TurboMist™ Nebulizer System is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Medline Industries, LP. The 510(k) number is K230602.

When was Hudson RCI® TurboMist™ Nebulizer System approved by the FDA?

Hudson RCI® TurboMist™ Nebulizer System received FDA 510(k) clearance on 2023-10-31, under approval number K230602.

What company makes Hudson RCI® TurboMist™ Nebulizer System?

Hudson RCI® TurboMist™ Nebulizer System is manufactured by Medline Industries, LP.

What is the FDA product code for Hudson RCI® TurboMist™ Nebulizer System?

The FDA product code for Hudson RCI® TurboMist™ Nebulizer System is CAF.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING

Other Devices by Medline Industries, LP

K220365Gemini Sterilization Wrap K221360Medline UNITE® Medial Malleolus Peg Plate System K220333Medline Orbis LVL 3 Surgical Gown K214108Medline Orbis Chemo Surgical Gown K220511Medline UNITE IM Fibula Implant K213567Medline UNITE Calcaneal Fracture Plating System

View all 29 devices →

Related Devices (Code: CAF)

K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc. K152882Propeller SystemReciprocal Labs K152482Propeller Sensor Model 2014-RReciprocal Labs K142541POCKET NEBMicrovaper Devices K170916Portable NebulizerMicrobase Technology Corporation

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.

↑