Cleared Abbreviated

TI NASAL MASK

K140980 · Respironics, Inc. · Anesthesiology
Feb 2015
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K140980 is an FDA 510(k) clearance for the TI 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 February 10, 2015, 300 days after receiving the submission on April 16, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K140980 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2014
Decision Date February 10, 2015
Days to Decision 300 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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