Cleared Traditional

ISO-GARD CLEARAIR MASK

K123176 · Teleflexmedical, Inc. · Anesthesiology
Feb 2013
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K123176 is an FDA 510(k) clearance for the ISO-GARD CLEARAIR MASK, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Teleflexmedical, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on February 14, 2013, 127 days after receiving the submission on October 10, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number K123176 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2012
Decision Date February 14, 2013
Days to Decision 127 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBN — Apparatus, Gas-scavenging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5430