Cleared Traditional

DISPOSABLE TRACH T OXYGENATOR

K811890 · Airlife, Inc. · Anesthesiology
Jul 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K811890 is an FDA 510(k) clearance for the DISPOSABLE TRACH T OXYGENATOR, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1981, 14 days after receiving the submission on July 1, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K811890 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1981
Decision Date July 15, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZA — Connector, Airway (extension)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5810

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