Cleared Traditional

AERONEB SOLO; AERONEB SOLO ADAPTER

K133360 · Aerogen, Ltd. · Anesthesiology
Oct 2014
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K133360 is an FDA 510(k) clearance for the AERONEB SOLO; AERONEB SOLO ADAPTER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on October 17, 2014, 350 days after receiving the submission on November 1, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K133360 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2013
Decision Date October 17, 2014
Days to Decision 350 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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