Cleared Traditional

CONCHASMART COLUMN

K141940 · Teleflex, Inc. · Anesthesiology
Nov 2014
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K141940 is an FDA 510(k) clearance for the CONCHASMART COLUMN, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Teleflex, Inc. (Durham, US). The FDA issued a Cleared decision on November 24, 2014, 130 days after receiving the submission on July 17, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K141940 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2014
Decision Date November 24, 2014
Days to Decision 130 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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