Cleared Traditional

AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER

K041418 · Cardinalhealth · Anesthesiology
Jun 2004
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K041418 is an FDA 510(k) clearance for the AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on June 10, 2004, 14 days after receiving the submission on May 27, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K041418 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2004
Decision Date June 10, 2004
Days to Decision 14 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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