Cleared Abbreviated

SIMPLE T YOUTH NASAL MASK

K140268 · Respironics, Inc. · Anesthesiology
Oct 2014
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K140268 is an FDA 510(k) clearance for the SIMPLE T YOUTH NASAL MASK, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 20, 2014, 250 days after receiving the submission on February 12, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K140268 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2014
Decision Date October 20, 2014
Days to Decision 250 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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