Cleared Traditional

AIRLIFE

K123527 · Care Fusion · Anesthesiology
Apr 2013
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K123527 is an FDA 510(k) clearance for the AIRLIFE, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Care Fusion (Waukegan, US). The FDA issued a Cleared decision on April 25, 2013, 160 days after receiving the submission on November 16, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K123527 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2012
Decision Date April 25, 2013
Days to Decision 160 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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