Cleared Traditional

PEDIATRIC OXYGEN MASKS

K811711 · Airlife, Inc. · Anesthesiology
Jul 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K811711 is an FDA 510(k) clearance for the PEDIATRIC OXYGEN MASKS, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981, 14 days after receiving the submission on June 17, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K811711 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1981
Decision Date July 01, 1981
Days to Decision 14 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