Cleared Traditional

Hudson RCI? TurboMist? Nebulizer System

K230602 · Medline Industries, LP · Anesthesiology
Oct 2023
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K230602 is an FDA 510(k) clearance for the Hudson RCI? TurboMist? Nebulizer System, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on October 31, 2023, 242 days after receiving the submission on March 3, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K230602 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2023
Decision Date October 31, 2023
Days to Decision 242 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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