Cleared Special

ISO-GARD MASK

K132729 · Teleflexmedical, Inc. · Anesthesiology
Jan 2014
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K132729 is an FDA 510(k) clearance for the ISO-GARD MASK, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on January 9, 2014, 128 days after receiving the submission on September 3, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number K132729 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2013
Decision Date January 09, 2014
Days to Decision 128 days
Submission Type Special
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