Cleared Traditional

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)

K223100 · Medline Industries, Inc. · Anesthesiology
Jun 2023
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K223100 is an FDA 510(k) clearance for the Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14), a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on June 27, 2023, 270 days after receiving the submission on September 30, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K223100 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date June 27, 2023
Days to Decision 270 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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