Cleared Abbreviated

AeroEclipse* ONE BAN

K200063 · Trudell Medical International · Anesthesiology
Jul 2020
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K200063 is an FDA 510(k) clearance for the AeroEclipse* ONE BAN, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on July 17, 2020, 186 days after receiving the submission on January 13, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K200063 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2020
Decision Date July 17, 2020
Days to Decision 186 days
Submission Type Abbreviated
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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