Cleared Traditional

PEDIATRIC OXYGEN OR AEROSOL MASKS,

K802323 · Airlife, Inc. · Anesthesiology
Oct 1980
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K802323 is an FDA 510(k) clearance for the PEDIATRIC OXYGEN OR AEROSOL MASKS,, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Airlife, Inc. (Walker, US). The FDA issued a Cleared decision on October 3, 1980, 10 days after receiving the submission on September 23, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K802323 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1980
Decision Date October 03, 1980
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYG — Mask, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5580