Cleared Traditional

K041418 - AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER (FDA 510(k) Clearance)

K041418 · Cardinalhealth · Anesthesiology device

Jun 2004

Decision

14d

Days

Class 2

Risk

K041418 is an FDA 510(k) clearance for the AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K041418 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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