Cleared Traditional

MISTY NEBULIZER

K802477 · Airlife, Inc. · Anesthesiology
Oct 1980
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K802477 is an FDA 510(k) clearance for the MISTY NEBULIZER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Airlife, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1980, 26 days after receiving the submission on October 5, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K802477 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1980
Decision Date October 31, 1980
Days to Decision 26 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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