Cleared Traditional

ISO-GARD MASK

K142138 · Teleflexmedical, Inc. · Anesthesiology
Oct 2014
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K142138 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 October 30, 2014, 86 days after receiving the submission on August 5, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number K142138 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2014
Decision Date October 30, 2014
Days to Decision 86 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