Cleared Special

Therapy Mask 3100 NC/SP

K231313 · Respironics, Inc. · Anesthesiology
Jul 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K231313 is an FDA 510(k) clearance for the Therapy Mask 3100 NC/SP, 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 July 28, 2023, 84 days after receiving the submission on May 5, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K231313 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2023
Decision Date July 28, 2023
Days to Decision 84 days
Submission Type Special
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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