Cleared Traditional

DUAL DIAL VENTURI STYLE MASK

K832725 · Airlife, Inc. · Anesthesiology
Sep 1983
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K832725 is an FDA 510(k) clearance for the DUAL DIAL VENTURI STYLE MASK, 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 September 20, 1983, 39 days after receiving the submission on August 12, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number K832725 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1983
Decision Date September 20, 1983
Days to Decision 39 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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