Cleared Traditional

Ventilator, Non-continuous (Respirator)

K201439 · Respironics, Inc. · Anesthesiology
Sep 2020
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K201439 is an FDA 510(k) clearance for the Ventilator, Non-continuous (Respirator), 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 September 25, 2020, 116 days after receiving the submission on June 1, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K201439 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2020
Decision Date September 25, 2020
Days to Decision 116 days
Submission Type Traditional
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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