Cleared Traditional

AirFit N20

K171212 · Resmed, Ltd. · Anesthesiology
Sep 2017
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K171212 is an FDA 510(k) clearance for the AirFit N20, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (Bella Vista Nsw 2153, AU). The FDA issued a Cleared decision on September 28, 2017, 156 days after receiving the submission on April 25, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K171212 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2017
Decision Date September 28, 2017
Days to Decision 156 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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