Cleared Traditional

DISPOSABLE THERMOPLASTIC RUBBER MOUTH

K821128 · Airlife, Inc. · Anesthesiology
May 1982
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K821128 is an FDA 510(k) clearance for the DISPOSABLE THERMOPLASTIC RUBBER MOUTH, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982, 23 days after receiving the submission on April 20, 1982. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K821128 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1982
Decision Date May 13, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYP — Mouthpiece, Breathing
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5620

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