Cleared Traditional

Comfort Flo Humidification System

K162242 · Teleflexmedical, Inc. · Anesthesiology
Jan 2017
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K162242 is an FDA 510(k) clearance for the Comfort Flo Humidification System, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on January 19, 2017, 162 days after receiving the submission on August 10, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K162242 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2016
Decision Date January 19, 2017
Days to Decision 162 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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