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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2023-10-31 under 510(k) 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. The listed applicant is Medline Industries, LP. The 510(k) number is K230602.

When did Hudson RCI® TurboMist™ Nebulizer System receive FDA 510(k) clearance?

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

Who is the listed applicant for Hudson RCI® TurboMist™ Nebulizer System?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

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

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

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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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