Cleared Traditional

AirFit N20

K153673 · Resmed, Ltd. · Anesthesiology
May 2016
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K153673 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 May 2, 2016, 133 days after receiving the submission on December 21, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K153673 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date May 02, 2016
Days to Decision 133 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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