Cleared Traditional

TRACH SWIVE/CONNECTOR

K833197 · Airlife, Inc. · Anesthesiology
Oct 1983
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K833197 is an FDA 510(k) clearance for the TRACH SWIVE/CONNECTOR, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 39 days after receiving the submission on September 19, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K833197 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1983
Decision Date October 28, 1983
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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