Cleared Traditional

TRACHEAL TUBES

K853051 · Erie Medical · Anesthesiology
Apr 1986
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K853051 is an FDA 510(k) clearance for the TRACHEAL TUBES, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Erie Medical (Milwaukee, US). The FDA issued a Cleared decision on April 11, 1986, 266 days after receiving the submission on July 19, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K853051 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1985
Decision Date April 11, 1986
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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