Cleared Traditional

SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)

K123614 · Trudell Medical Intl. · Anesthesiology
Mar 2013
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K123614 is an FDA 510(k) clearance for the SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS), a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on March 11, 2013, 108 days after receiving the submission on November 23, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K123614 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2012
Decision Date March 11, 2013
Days to Decision 108 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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