Cleared Traditional

UNIVERSAL ADAPTER SYSTEM-U/ADAPIT

K811708 · Airlife, Inc. · Anesthesiology
Jul 1981
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K811708 is an FDA 510(k) clearance for the UNIVERSAL ADAPTER SYSTEM-U/ADAPIT, 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 1, 1981, 15 days after receiving the submission on June 16, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K811708 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1981
Decision Date July 01, 1981
Days to Decision 15 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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