Cleared Traditional

AirLife Misty Finity Nebulizer

K153748 · Care Fusion · Anesthesiology
May 2017
Decision
505d
Days
Class 2
Risk

About This 510(k) Submission

K153748 is an FDA 510(k) clearance for the AirLife Misty Finity Nebulizer, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on May 17, 2017, 505 days after receiving the submission on December 29, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K153748 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2015
Decision Date May 17, 2017
Days to Decision 505 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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