Cleared Traditional

VENNER TRACHEAL SEAL MONITOR

K110631 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology
Jul 2011
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K110631 is an FDA 510(k) clearance for the VENNER TRACHEAL SEAL MONITOR, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Venner Medical (Singapore) Pte, Ltd. (Rockville, US). The FDA issued a Cleared decision on July 28, 2011, 146 days after receiving the submission on March 4, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K110631 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2011
Decision Date July 28, 2011
Days to Decision 146 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750

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