Cleared Traditional

PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN

K812066 · Airlife, Inc. · Anesthesiology
Aug 1981
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K812066 is an FDA 510(k) clearance for the PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN, a Mask, Oxygen, Low Concentration, Venturi (Class I — General Controls, product code BYF), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1981, 13 days after receiving the submission on July 21, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number K812066 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1981
Decision Date August 03, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYF — Mask, Oxygen, Low Concentration, Venturi
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5600

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