Cleared Abbreviated

AF541 SE Full Face Mask

K150638 · Respironics, Inc. · Anesthesiology
Sep 2015
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K150638 is an FDA 510(k) clearance for the AF541 SE Full Face Mask, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 18, 2015, 191 days after receiving the submission on March 11, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K150638 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2015
Decision Date September 18, 2015
Days to Decision 191 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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