Cleared Abbreviated

Simple T Pediatric Nasal Mask

K151120 · Respironics, Inc. · Anesthesiology
Apr 2016
Decision
354d
Days
Class 2
Risk

About This 510(k) Submission

K151120 is an FDA 510(k) clearance for the Simple T Pediatric 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 April 15, 2016, 354 days after receiving the submission on April 27, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K151120 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2015
Decision Date April 15, 2016
Days to Decision 354 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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