Cleared Traditional

SINGLE USE NEBULIZER, ADJUST. AIR-

K830895 · Airlife, Inc. · Anesthesiology
Apr 1983
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K830895 is an FDA 510(k) clearance for the SINGLE USE NEBULIZER, ADJUST. AIR-, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983, 38 days after receiving the submission on March 21, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K830895 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1983
Decision Date April 28, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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